Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units
Phase: NA
Conditions: Critical Illness, Respiratory Disease
Sponsor: Fondation Hôpital Saint-Joseph

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Evaluation of the impact of lung and diaphragm ultrasound findings on 
clinical decisions for chest physiotherapy in patients hospitalized in 
Intensive Care Units 
 
US-ADEPT: UltraSound for Accurate Decisions in chest PhysioTherapy 
……………….. 
 
RESEARCH PROTOCOL 
 
Principal investigators: 
Aymeric LE NEINDRE 
Bélaid BOUHEMAD 
George NTOUMENOPOULOS 
 
Secondary investigators: 
 
 
 
Registered at Clinicaltrial NCT02881814

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Summary 
1. Context and rationale ...................................................................................................... 34 
2. Research hypothesis ........................................................................................................ 45 
3. Objectives ........................................................................................................................... 5 
3.1. Principal objective ...................................................................................................... 5 
3.2. Secondary objectives .................................................................................................. 5 
4. Judgement criteria .......................................................................................................... 56 
4.1. Principal judgement criterion ................................................................................. 56 
4.2. Secondary clinical decision-making judgement criteria ....................................... 56 
5. Inclusion/exclusion criteria: ........................................................................................... 67 
5.1. Inclusion criteria ....................................................................................................... 67 
5.2. Exclusion criteria ........................................................................................................ 7 
6. Methodology: ................................................................................................................... 78 
6.1. Type of study ............................................................................................................. 78 
6.2. Study flow chart ........................................................................................................ 89 
6.3. Study location .......................................................................................................... 910 
6.4. Study population ..................................................................................................... 910 
6.5. Intervention: nature of the routine care to be evaluated .................................... 910 
6.5.1. Procedure 1: Decision-making process in chest physiotherapy ......................... 910 
6.5.2. Procedure 2: lung and diaphragm US .............................................................. 1213 
7. Study progress ............................................................................................................. 1516 
7.1. Study planning ...................................................................................................... 1516 
7.2. Recruitment method ............................................................................................. 1516 
7.3. Number of patients to recruit and duration of participation for each patient ... 16 
7.4. Data collected ........................................................................................................ 1617 
7.4.1. Pre-inclusion visit ............................................................................................ 1617 
7.4.2. Inclusion visit ................................................................................................... 1617 
7.4.3. Initial clinical physiotherapist visit .................................................................. 1817 
7.4.4. Ultrasound physiotherapist/operator visit ........................................................ 1817 
7.4.5. LUS reporting to clinical physiotherapist and intensivist ................................ 1918 
7.4.6. Chest physiotherapy treatment by the clinical physiotherapist ........................ 1918 
7.4.7. Patient follow-up synthesis .................................................................................. 19 
7.5. Patient monitoring ................................................................................................ 2119 
7.6. Research stopping rules ....................................................................................... 2119 
8. Statistical analysis ....................................................................................................... 2120 
8.1.1. Modification of the clinical decision ............................................................... 2120 
8.1.2. Modification of the clinical decision when a chest CT-scan < 12h is available
 
2221 
8.1.3. Proportion of agreement between clinical and LUS diagnosis ........................ 2221 
8.1.4. Proportion of cases when the chest physiotherapy protocol is modified following 
the results of the LUS: .................................................................................................. 2321 
8.1.5. Modification of the intensivist clinical decision .............................................. 2421 
9. Expected benefits for patients .................................................................................... 2522 
10. Risks for patients taking part in the study .............................................................. 2522 
12. Justification for current care ................................................................................... 2423 
13. Funding ...................................................................................................................... 2623 
14. Ethical and regulatory aspects ................................................................................. 2623 
14.1. Information to patients ...................................................................................... 2623 
14.2. Need to submit the study for approval by an ethics committee ..................... 2624 
15. Bibliography .............................................................................................................. 2725 
16. Annexes ...................................................................................................................... 3028 

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1. Context and rationale 
In Intensive Care Unit (ICU), the physiotherapist may be involved in the respiratory 
management of patients, notably with regard to lung aeration disorders, swallowing disorders, 
weaning from mechanical ventilation, aerosol therapy, oxygen therapy and the 
implementation of non-invasive ventilation (NIV), but this practice may vary 
internationally(1–3). 
Chest physiotherapy techniques are selected following a systematic evaluation often based on 
clinical examination, review of measures of cardiopulmonary function/laboratory tests and 
review of any radiological tests. Evaluation of the patient is essential to determine the need 
for chest physiotherapy, treatment selection, monitoring the evolution of the patient and to 
evaluate treatment efficacy. Chest physiotherapy aims to improve airway clearance, alveolar 
recruitment and ventilation/perfusion matching (2). It typically involves techniques often used 
in combination (4), and the selection of interventions depends on the pulmonary dysfunction 
suspected. For example, in the case of retained airway secretions, airway clearance techniques 
(including patient re-positioning head down and manual chest wall vibrations/compressions 
and airway suctioning) may be used to promote secretion removal, reducing airway 
resistance, optimizing lung compliance and decreasing work of breathing (2). For lung 
collapse/consolidation, chest physiotherapy aims to improve lung recruitment, compliance 
and ventilation/perfusion matching. For example, positioning and lung hyperinflation may be 
used to re-expand atelectasis (2,5). Non-invasive ventilation, intrapulmonary percussive 
ventilation may be additional strategies optimise lung volume restoration and facilitate 
secretion clearance respectively (2,5,6). 
Physiotherapist usually uses a clinical examination, including lung auscultation, and measures 
of physiological function including the analysis of blood gases and chest imaging findings (7). 
However, the reduced diagnostic accuracy of the chest x-ray and lung auscultation with 
regard to the conditions that may require chest physiotherapy such as pulmonary 
consolidation, pleural effusion, atelectasis or interstitial syndrome (8), implies that clinical 
decision-making may be less than optimal. Chest CT-scan is the gold-standard reference 
examination for the evaluation of acute lung injuries (9)but this requires transportation of the 
critically ill patient, which involves patient risk and additional exposure to radiation. 
As an alternative to the CT-scan, lung ultrasound (LUS) presents greater sensitivity and 
specificity than chest X-ray in the diagnosis of these same diseases. LUS can also be used to 
assess the diaphragm with greater accuracy and reproducibility than is the case using routine 

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measurement tools which often provide only global measures of respiratory dysfunction 
(Maximal Inspiratory Pressure (MIP). Whereas, LUS can also be used to identify diaphragm 
dysfunction (both bilateral and unilateral dysfunction) with excellent sensitivity and 
specificity compared with standard of transdiaphragmatic measurements of pressure(10). 
Physiotherapists working in critical care may be developing the skills to undertake LUS to 
assess their patients (9, 10). Lung and diaphragm US assessments may allow them to 
determine the optimal indications for chest physiotherapy and thus avoid unnecessary or 
inappropriate treatments (9, 10). The information provided by LUS may modify the 
physiotherapist’s therapeutic management. Given the relatively recent discussions on the use 
of lung and diaphragm US in chest physiotherapy (11,12), the usefulness of this tool for 
physiotherapy in critical care has never been evaluated. Xirouchaki et al. (13)assessed the 
impact of LUS on clinical decisions in critically-ill patients by intensivist sand demonstrated 
that it significantly affected the medical diagnosis and modified the therapeutic management. 
Also a recent case report highlighted the impact of LUS on the clinical decision-making by 
physiotherapists in critical care (14). As far as we are aware, no study has prospectively and 
systematically evaluated the impact of the information provided by LUS on clinical-decision 
making by physiotherapists in the use of chest physiotherapy in patients hospitalized in an 
ICU. 
2. Researchhypothesis 
The lung and diaphragm ultrasound findings provided to the physiotherapist will modify 
his/her clinical decision-making in regards to chest physiotherapy treatment in the critical care 
patient. 
 
 

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3. Objectives 
3.1. Principal objective 
The principal objective of this study is to evaluate the impact of using the results of lung and 
diaphragm US on clinical decisions by physiotherapists regarding chest physiotherapy in 
patients hospitalized in an ICU. 
3.2. Secondary objectives 
The secondary objectives are to: 
1. Determine whether LUS has an impact on clinical decisions in chest physiotherapy: 
o When the findings from a chest CT-scan less than 12hours old are available; 
o For each clinical hypotheses; 
o For each level of certainty of clinical hypothesis; 
o For type of patients (reasons for admission the most represented); 
o For each research center. 
2. Determine the level of agreement between the physiotherapist’s diagnosis comparing 
the clinical vs LUS findings, overall, for the level of certainty of clinical diagnosis and 
for the population where a CT-scan is available; 
3. Determine the frequency of changes in the chest physiotherapy following the 
assessment of the LUS results, overall and for each type of clinical hypothesis; 
4. Determine the frequency of changes in the medical treatment (determined by 
intensivist) following the assessment of the LUS results performed by the 
physiotherapist, overall and for each type of clinical hypothesis. 
4. Judgement criteria 
4.1. Principal judgement criterion 
Modification of the clinical decision: agreement (yes/no) between the lung and diaphragm 
US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy 
protocol, expressed using the Net Reclassification Index (NRI). 
4.2. Secondary clinical decision-makingjudgementcriteria 
1. Modification of the clinical decision: 
o When a chest CT-scan < 12h is available; 
o For each clinical hypotheses; 
o For the level of certainty of clinical hypotheses (Likert scale: strongly certain, 
certain, neither certain nor uncertain, uncertain, strongly uncertain); 

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o For type of patients (reasons for admission the most represented); 
o For each research center. 
2. Proportion of agreement between clinical and LUS diagnosis: 
o Overall; 
o For the level of certainty of clinical hypotheses (Likert scale: strongly certain, 
certain, neither certain nor uncertain, uncertain, strongly uncertain); 
o When chest CT-scan < 12h is available. 
3. Proportion of cases when the chest physiotherapy protocol is modified following the 
results of the LUS: 
o Overall; 
o For each type of clinical hypothesis; 
o When a chest CT-scan < 12h is available; 
4. Modification of the clinical decision of intensivist: 
o Overall; 
o For each type of clinical hypothesis; 
o When a chest CT-scan < 12h is available. 
5. Inclusion/exclusion criteria: 
5.1. Inclusion criteria 
Patients presenting the following criteria will be eligible: 
- Hypoxemia(SpO2/FiO2< 315 (15))(indication for chest physiotherapy)(cf. annexe 1); 
- Medical prescription for chest physiotherapy; 
- First session of chest physiotherapy; 
- Chest X-ray<12h available; 
- Physiotherapist/operator qualified in LUS available; 
- Patient’s consent. 
 
 

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5.2. Exclusion criteria 
Patients presenting the following criteria will not be eligible: 
- Presence of a contra-indication for chest physiotherapy; 
- Absence of hypoxemia; 
- Absence of a prescription for chest physiotherapy; 
- Absence of a chest X-ray < 12h from the time of physiotherapy assessment; 
- Physiotherapist/operator qualified in LUS not available; 
- Lung and diaphragm US not possible (surgical emphysema, dressing, scarring, 
drains etc.); 
- Refusal of the patient or a relative to participate in the study; 
- Patients to be discharged on the day of the study; 
- Patients in palliative care; 
- Withdrawal/limitations of medical care with impending death. 
6. Methodology: 
6.1. Type of study 
This is a multi-centre prospective (patients enrolled on admission) interventional study 
evaluating a routine assessment/treatment. The study intends to assess the impact of lung and 
diaphragm ultrasound on the usual physiotherapist’s clinical decision-making process. Each 
included patient will be clinically assessed by a clinical physiotherapist, and then will have a 
lung and diaphragm ultrasound by another physiotherapist/operator blinded to the clinical 
assessment findings. The lung and diaphragm ultrasound findings will then be presented to 
both the intensivist and clinical physiotherapist to evaluate the impact on the independent 
clinical decision-making by both the intensivist and physiotherapist. 

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6.2. Studyflow chart 
 
 
 

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6.3. Study location 
- Surgery Intensive Care Unit Department, CHU de Dijon, Dijon, France 
- Respiratory Intensive Care Unit and Post-Critical care rehabilitation unit, Hôpital Forcilles, 
Férolles-Attilly, France 
- Medical and surgical Intensive Care Unit Department, Saint-Joseph Hospital Network, 
Paris, France 
- St Vincent’s Hospital, Sydney Australia 
6.4. Study population 
Patients over 18 hospitalized in the ICU and presenting hypoxemia (SpO2/FiO2< 315) and 
who have not been previously given chest physiotherapy on this ICU admission. 
6.5. Intervention: nature of the routine care to be evaluated 
6.5.1. Procedure 1: Decision-making process in chest physiotherapy 
6.5.1.1. 
Clinical physiotherapist  training 
The clinical physiotherapist is the physiotherapist who manages patients in the ICU. He is a 
trained critical care physiotherapist with more than two years of experience, as defined by the 
French statement for physiotherapist working in the French ICU’s(1). The clinical 
physiotherapist in the Australian ICU will have been trained and oriented to working in the 
ICU based on a local structured training program dependent on the level of experience of the 
physiotherapist. 
6.5.1.2. 
Indication and prescription of chest physiotherapy 
In the French ICU departments, the intensivist prescribes chest physiotherapy for patients, 
whereas in the Australian setting, the physiotherapist screens all patients admitted to intensive 
care and provides interventions based on clinical need. All patients with hypoxemia 
(SpO2/FiO2< 315) will result in referrals for chest physiotherapy by the intensivists in the 
French ICU(5).All patients with hypoxemia (SpO2/FiO2< 315) will be reviewed by the 
physiotherapists in the Australian ICU as to the requirements for physiotherapy. 
6.5.1.3. 
Clinical examination 
When chest physiotherapy is prescribed by the intensivist in the French ICU (or the patient 
has indications for chest physiotherapy in the Australian ICU as stated 6.5.1.2), the clinical 
physiotherapist carries out a clinical examination and will analyse the complementary tests 
(chest X-ray, chest CT-scan and blood gases if available). He/she also consults the patient’s 
medical record to identify reasons for admission to the ICU and the working medical 
diagnosis if the critical care physician has made one. 

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The physiotherapists’ clinical examination includes: 
- Patient observation: 
o Thoracic cage observation: asymmetry of chest wall movement, 
hyperinflation etc. 
o Respiratory breathing pattern: respiratory rate, dyspnoea, tachypnoea, 
bradypnoea, Hoover sign, Campbell sign, respiratory pattern (thoracic 
expansion, abdominal expansion, paradoxical chest or abdominal 
movement); 
o Physiologic data: SpO2, heart rate, blood pressure; 
- Chest wall palpation: vocal fremitus, tactile chest wall fremitus, subcutaneous 
emphysema; 
- Chest wall percussion: dullness or tympanism; 
- Lung Auscultation: 
o Normal breath sound: vesicular sound, bronchial sound; 
o Abnormal sound: crackles, rhonchi, wheeze etc. 
Then, the physiotherapist interprets the additional tests: 
- Chest X-rays: opacities, consolidation, volume loss, bronchogram, pneumothorax, 
pulmonary oedema; 
- Chest CT-scan (if available):opacities, emphysema pneumothorax, pulmonary 
oedema; 
- Arterial blood gas: hypoxemia (PaO2<75-80 mmHg), hypercapnia (PCO2> 45 
mmHg), acidosis (pH <7,30), alkalosis (pH >7,44). 
After the analysis of the clinical examination findings, the physiotherapist then determines 
one or several working clinical hypothesis. 
6.5.1.4. 
Clinical hypotheses 
Following the examination, he/she will put forward one or several hypotheses concerning the 
respiratory dysfunction (and not the medical diagnosis) and will either confirm or refute the 
indications for chest physiotherapy (cf. annexe 2a). If chest physiotherapy is indicated, the 
physiotherapist will specify the protocol to be used. The choice of the treatment modalities 
with regard to the type of respiratory dysfunction is detailed in annexe 2b. 
 
According to the clinical examination, the clinical physiotherapist formulates one or more of 
the following clinical hypothesis (cf annexe 2a): 
- Clinical examination is compatible with retained airway secretions; 
- Clinical examination is compatible with bronchospasm; 

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- Clinical examination is compatible with pneumonia/consolidation; 
- Clinical examination is compatible with atelectasis (passive or obstructiveactive 
mechanism); 
- 
- Clinical examination is compatible with pleural effusion; 
- Clinical examination is compatible with pulmonary edema or global interstitial 
syndrome; 
- Clinical examination is compatible with pneumothorax; 
- Clinical examination is compatible with reduced aeration at the most dependent parts 
of the lungs; 
- Clinical examination is compatible with unilateral diaphragm dysfunction (unilateral 
or bilateral); 
- Clinical examination is compatible with bilateral diaphragm dysfunction; 
- Clinical examination is inconclusive. 
Among the formulated clinical hypotheses, the clinical physiotherapist will choose one 
primary clinical hypothesis (the choice is left to the discretion of the clinical physiotherapist, 
based on the probability and priority of the clinical hypothesis in terms of treatment). 
A lung and diaphragm US will be done (see below) following the evaluation of the clinical 
physiotherapist with the physiotherapist who undertakes the US assessment blinded to the 
clinical assessment findings of the clinical physiotherapist. The clinical physiotherapist will 
then incorporate the results of the lung and diaphragm US and deem whether they are 
compatible with the clinical hypotheses put forward. He/she will then specify the 
chestphysiotherapy protocol according to the results of the US-scan. 
6.5.1.5. 
Choice of chest physiotherapy treatment 
The clinical physiotherapist will define the chest physiotherapy treatment modalities 
according to the formulated clinical hypothesis. The following treatments may be proposed : 
- No chest physiotherapy treatment indicated; 
- Refer to the intensivist; 
- Non-invasive ventilation; 
- CPAP (if non-ventilated patient) or PEEP modifications (if ventilated patient); 
- Manual or ventilator hyperinflation; 
- Mechanical in-exsufflator (Cough Assist ©); 
- Rib cage compressions, manual assisted cough; 
- Endo or naso-tracheal suctioning; 
- Positioning: 

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o Semirecumbent position (head 45° from bed); 
o Laterocubitus; 
- Early mobilization: 
o Sitting on side of bed; 
o Standing; 
o Sitting on chair. 
The choice of treatment according the clinical hypothesis is defined in annexe 2b. The clinical 
physiotherapist will define the chest physiotherapy treatment modalities for the primary 
clinical hypothesis. The chest physiotherapy treatment modalities will be defined both before 
and again separately after the LUS and Diaphragm US examination. 
6.5.2. Procedure 2: Lung and diaphragm US 
6.5.2.1. 
Ultrasound physiotherapist/operator 
The LUS will be performed by the physiotherapist/operator, who will be blinded to the 
clinical evaluation by clinical physiotherapist, the patient’s status including the Chest X-rays 
and CT-scan findings and all of other clinical information. The operator will not take part in 
the management of the patients concerned. 
The ultrasound training of the operator in the French ICU was performed as follow: 
- Two days academic theoretical and practical training; 
- One year supervised lung ultrasound practice: more than 200 supervised thoracic 
ultrasound examination performed; 
- Two years autonomous thoracic ultrasound practice. 
The Australian ICU used a modified version of this training program with a one day 
theoretical and practical training course and supervised lung ultrasound practice. 
6.5.2.2. 
Ultrasound examination modalities 
A referent intensivist will be present when LUS is performed by a french physiotherapist, in 
order to control the adequate realization of LUS examination. Referent intensivist are trained 
to LUS. Dr Laurence DONETTI (Forcilles’ Hospital), Dr Marc TRAN (St. Joseph’s Hospital) 
and Pr Belaid BOUHEMAD (Universitary Hospital of Dijon) will be referent intensivist. 
The CX 50 (Philips) or Edge (Sonosite) ultrasound machine, with 3.5 MHz convex and 10 
MHz linear probes, will be used. The convex probe will be used to assess the lung (interstitial 
syndrome, consolidation, pneumothorax, diaphragm excursion and pleural effusion) and the 
linear probe will be used to assess to evaluate diaphragm thickness. 
The patient will be in semirecumbent position (head 30° from bed) for LUS imaging. Two 
lines delimit the axillary space: the anterior and posterior axillary lines. These lines define 

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areas of investigation for each hemithorax—anterior, lateral, andposterior—each of which is 
divided into upper and lower parts. Each hemithorax includes 6 examination areas (cf annexe 
3a). The locations of the liver and spleen allow for the identification of the right and left 
diaphragm cupolas, which separate the thoracic and abdominal compartment. The probe will 
be used to explore each intercostal space using a longitudinal view. Specific examination 
modalities for the diaphragm ultrasound are defined in annexe 3a. 
6.5.2.3. 
Lung and diaphragm ultrasoundsemiology 
The basics lung ultrasound semiology is described in annexe 3b. The following syndromes 
will be searched for: normal profile, alveolar-interstitial syndrome, pulmonary consolidation, 
pleural effusion, pneumothorax and diaphragm dysfunction (16).  
The ultrasound syndromes are defined by the following signs in a scanned for the in six-lung 
zones of each chest wall of the patient: 
Normal lung: 
- Bat sign; 
- A lines; 
- Pleural sliding (seashore sign). 
A normal profile is compatible with presence of tracheo-bronchial retained secretions and 
bronchospasm. 
 
Alveolar-interstitial syndrome(16–18): 
- A positive region is defined by the presence of three or more B-lines in a 
longitudinal plane between two ribs; 
- In the anterior and lateral thoracic areas; 
- Multiple and well-defined B-lines: moderate loss of lung aeration; 
- Confluent B-lines: severe loss of lung aeration. 
The presence of a focal sonographic pattern of interstitial syndrome is compatible with 
pneumonia, atelectasis or pulmonary contusion. 
The presence of multiple diffuse bilateral B-lines is compatible with pulmonary oedema or 
ARDS. In the case of pulmonary oedema, the interstitial syndrome is diffuse, homogeneous 
and bilateral. In the case of ARDS, the interstitial syndrome is diffuse, heterogeneous, 
bilateral and associated with pleural abnormalities and sub-pleural consolidations. 
 
Lung consolidation: 
- Subpleural echo-poor region or tissue-like echo-structure; 
- Atelectasis pattern(19,20): 

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o Abolished pleural sliding; 
o Static air bronchogram; 
o Lung pulse; 
o Passive atelectasis due to compression from the surrounding pleural 
effusion: homogeneous echogenic structure into the pleural effusion, 
with smooth margin and linear air bronchogram(21). 
- Pneumonia pattern(22–25): 
o Irregular deep margin when the consolidation is partial; 
o Regular deep margin when consolidation involves an entire lobe; 
o Static or dynamic air bronchogram; 
o Fluid bronchogram; 
o Vascular pattern; 
o Bilateral or unilateral. 
The aim of physiotherapist is not to identify the medical diagnosis. Regarding the presence of 
the interstitial syndrome and lung consolidation, the aim is to also define the level of lung 
aeration present in each of the 12 lung zones: 
- Normal aeration (N): presence of lung sliding with A-lines or fewer than two 
isolated B-lines; 
- Moderate loss of lung aeration (B1): multiple, well-defined B-lines (B1 lines); 
- Severe loss of lung aeration (B2): multiple, coalescent B-lines (B2-lines); 
- Lung consolidation (C): presence of a tissue pattern. 
Points will be allocated according to the worst ultrasound pattern observed: N=0, B1=1, 
B2=2, C=3. Sum of scores for each area defines the LUS score, ranging between 0 and 
36(26).The qualitative description of the consolidation allows the physiotherapist to 
differentiate atelectasis or pneumonia pattern and the adaptation of the chest physiotherapy 
treatment (cf annexe 2b). 
 
Pleural effusion (16): 
- Anechoic or hypoechoic structure ; 
- Quad sign ; 
- Sinusoidsign ; 
- Transudates are always anechoic, while exudates are echoic and loculated (18). 
 
Pneumothorax (16) : 
- Lung point; 

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- Absence of pleural sliding (stratospheric sign); 
- Absence of B-lines; 
- Absence of lung pulse. 
 
Diaphragmdysfunction : 
- Diaphragm excursion < 2,5 cm(27); 
- Diaphragmthickening fraction < 20% (28). 
6.5.2.4. 
Lung and diaphragm ultrasound report 
The physiotherapist/operator will write a detailed LUS-scan report, which will be given to the 
clinical physiotherapist. When LUS is performed by a french physiotherapist, the LUS report 
will be checked and validated by the referent intensivist. The LUS-scan reportIt will include 
the LUS and Diaphragm diagnosis and describe the signs observed in the different regions of 
the chest (cf. annexe4). The clinical physiotherapist is trained to interpret LUS reports. The 
clinical physiotherapist then determines the options or changes to treatment based on the US 
findings. 
7. Studyprogress 
7.1. Study planning 
- Ethic comittee submission: December 2016; 
- Study comencement: January 2016; 
- Inclusion duration : 12 months; 
- Length of patient participation: one day; 
- End of inclusion: January 2017; 
- Total duration of the study: 18 months; 
- Congress communications: French Intensive Care Society Congress, ESICM, ERS, 
ATS, from April 2018; 
- Publication: September 2018; 
- Target journal: Physical therapy, Intensive Care Medicine or Critical Care Medicine. 
7.2. Recruitment method 
Patients will be recruited in the Surgical ICU of the CHU de Dijon, Medical-Surgical ICU of 
Paris St. Joseph’s Hospital, Respiratory ICU and Post-ICU Rehabilitation Unit of Forcilles’ 
Hopital and the ICU of St Vincent’s Hospital. 
Patients admitted to the ICU and who meet the inclusion criteria will be invited to take part in 
the study. Patients with hypoxemia will be identified by the duty physician at the time of 

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transfer to the unit or by the principal investigator and the coordinating investigator during the 
day. Written informed consent will be collected (cf. annexes 5a and 5b). 
7.3. Number of patients to recruit and duration of participation for each 
patient 
Given the high prevalence of hypoxemia in ICUs, the systematic respiratory assessment in 
these patients by the physiotherapist and our relatively non-restrictive inclusion criteria, we 
believe we can recruit more than 300 patients per year. 
7.4. Data collected 
7.4.1. Pre-inclusion visit 
The pre-inclusion visit takes place as soon as a patient meeting the inclusion criteria is 
hospitalized in the ICU department. During this visit, the principal investigator will give the 
patient or his relatives the information consent (cfannexe5). If the patient gives his/her 
consent, he/she will be included in the study. 
7.4.2. Inclusion visit 
The following data will be collected: 
- 
Demographic: age, sex, size, weight, BMI, smoking, alcohol consumption, history of 
cirrhosis, diabetes or a chronic respiratory disease, heart failure; 
- 
Reason for hospitalization: 
o Chronic respiratory disease decompensation : COPD, obesity hypoventilation, 
restrictive lung disease; 
o Acute severe asthma; 
o Community-acquired and hospital-acquired pneumonia; 
o ARDS; 
o Acute respiratory distress: infection, acute pulmonary edema, other identified 
causes, other non identified causes. 
o Pulmonary embolism; 
o Post-operative (urologic, digestive, vascular, and thoracic surgery); 
o Sepsis; 
o Coma; 
o Acute heart failure; 
o Multi-organ failure; 
o Cancer; 
o Continous monitoring; 
o Other (detail). 

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- 
Medical diagnosis and medical treatment planned of hypoxemia (or cause of 
hypoxemia). 
 
 

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7.4.3. Initial clinical physiotherapist visit 
The clinical physiotherapist undertakes the patient clinical examination, reviews the chest x-
rays and additional tests as available. Moreover, he/she reviews the CT-scan if performed < 
12h at the patient’s admission including the radiology report. Following the clinical 
examination, the clinical physiotherapist formulates his/her clinical hypotheses. Among this 
formulated clinical hypotheses, the physiotherapist chooses a primary clinical hypotheses (the 
choice is left to the discretion of the clinical physiotherapist, based on the probability and 
priority of the clinical hypothesis in term of treatment). The primary clinical hypothesis and 
the secondary clinical hypotheses (if adapted) will be recorded in the case report form (CRF). 
According the primary clinical hypothesis, the clinical physiotherapist records his chest 
physiotherapy treatment modalities in the CRF. 
The following data will be recorded: 
- 
Medical management: 
o Hypnotics (and dose); 
o Opiates (and dose); 
o Steroids (and dose); 
o Anti-hypertensives (and dose); 
o Antibiotics (and dose); 
o Oxygen therapy (and flow); 
o Mechanical ventilation, NIV (PEEP, IPAP, O2 dose); 
o Tracheotomy; 
- 
Severity score: SAPSOFA 
- 
Vital signs: RR, HR, BP SpO2, FiO2 (true or estimated), body temperature, RASS, 
Glasgow coma score; 
- 
Clinical hypotheses of the clinical physiotherapist; 
- 
Choice of chest physiotherapy protocol (before LUS). 
7.4.4. Ultrasound physiotherapist/operator visit 
Following the clinical physiotherapist visit, the ultrasound physiotherapist/operator performs 
a lung and diaphragm ultrasound. He is blinded to the patient’s status and clinical 
physiotherapist examination. He/she is not involved in patient management or patient clinical 
decision-making. The ultrasound findings are recorded in the LUS report (cfannexe4). The 
LUS report is reported to the clinical physiotherapist and to the intensivist. The ultrasound 
diagnosis(es) is recorded. 

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7.4.5. LUS reporting to clinical physiotherapist and intensivist 
The clinical physiotherapist and intensivist reviews the LUS report. Taking into account these 
LUS report, the clinical physiotherapist once again selects the chest physiotherapy treatment 
modalities indicated. The second chest physiotherapy treatment modalities will be recorded, 
with the reasons for a change of interventions (if indicated). The intensivist will again review 
any medical decisions that have been made. The new medical treatment for hypoxemia (or 
cause of hypoxemia) is recorded. 
7.4.6. Second visit of the clinician physiotherapist: implementation of the 
chest physiotherapy treatment 
After the review of the LUS report, the clinical physiotherapist may or may not decide to 
perform the chest physiotherapy treatment, to refer the patient to the intensivist, dependent 
upon his/her therapeutic strategy choice. The executed chest physiotherapy treatment 
provided will be recorded. The following data will be recorded: 
- 
Current medical management: 
o Oxygen therapy (and flow); 
o Mechanical ventilation, NIV (PEEP, IPAP); 
- 
Severity score: SOFA 
- 
Vital signs: RR, HR, BP SpO2, FiO2 (true or estimated), body temperature, RASS, 
Glasgow coma score; 
- 
Adverse effects during the chest physiotherapy treatment: 
o Desaturation (< 4% of initial SpO2); 
o Decrease or increase of blood pressure (> 20% of initial SBP or DBP); 
o Decrease or increase of heart rate (> 20% of initial heart rate); 
o Endotracheal tube removal; 
o Catheter or perfusion removal. 
7.4.7. End-research visit 
When the patient is deceased or left the ICU, the following data will be recorded : 
- 
ICU length of stay (day); 
- 
Intubation (yes/no); 
- 
Duration of mechanical ventilation (if adapted) (day); 
- 
Number of extubation failure (if adapted) (yes/no); 
- 
Vital status (alive/deceased); 
- 
Duration of médical treatment present at the day of inclusion: antibiotics, 
hypnotics, opiates, steroids and anti-hypertensives (day). 
 

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7.4.8. Patient follow-up synthesis 
 
Pre-
inclusion 
J 0 
Inclusion 
J 0 
First clinical 
physiotherapist 
visit 
J 0 
LUS 
J 0 
LUS results 
reading by the 
clinical 
physiotherapist 
and intensivist 
J 0 
Second clinical 
physiotherapist 
visit 
J 0 
End-
research 
visit 
Information consent 
✓ 
 
 
 
 
 
 
Demographic data 
 
✓ 
 
 
 
 
 
Reason for 
hospitalization, 
medical diagnosis if 
different 
 
✓ 
 
 
 
 
 
Medical management 
 
 
✓ 
 
 
✓ 
 
SAPSOFA, vital signs 
 
 
✓ 
 
 
✓ 
 
Medical diagnostic for 
respiratory condition 
 
✓ 
 
 
 
 
 
Medical treatment 
planned for respiratory 
condition 
 
✓ 
 
 
 
 
 
Clinical hypotheses of 
the 
clinical physiotherapist 
 
 
✓ 
 
✓ 
 
 
Choice of chest 
physiotherapy protocol 
 
 
✓ 
 
✓ 
 
 
LUS scan 
 
 
 
✓ 
 
 
 
LUS-scan report 
 
 
 
✓ 
✓ 
 
 
New choice of chest 
physiotherapy protocol 
 
 
 
 
 
✓ 
 
Adverse effect 
recording 
 
 
 
 
 
✓ 
 
New medical 
treatment planned for 
hypoxemia 
 
 
 
 
✓ 
 
 
ICU length of stay, 
duration of MV, vital 
status 
 
 
 
 
 
 
✓ 
The data will then be entered in an e-CRF (Redcap.com) and analysed at the St. Joseph 
Hospital Network. 
The statistical analysis will be conducted by the Clinical Research Centre (CRC) of the St. 
Joseph Hospital Network. An identifier will be attributed to each patient (initials of first name 
and family name – year of birth) and the data will be entered on an EXCEL file, which will be 
sent to the statistician in charge of the analysis at the St. Joseph Hospital Network. 
 
 

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7.5. Patient monitoring 
None. 
7.6. Research stopping rules 
The definitive research stopping occurs when a patient meets the exclusion criteria. All of the 
study exit are defined and recorded in the CRF. 
8. Statistical analysis 
8.1. Calcul of number of subject 
This is a pilot study and we don’t have any information about the proportion of clinical 
decision modification in chest physiotherapy when the physiotherapist uses LUS information.  
The clinical experience of the investigators (A Le Neindre and G Ntoumenopoulos) allows to 
estimate an expected NRI of 30%. We want at least 50 events (clinical decision modification). 
So, we aim to include 150 patients in this study. 
8.2. Statistical method 
8.2.1. Modification of the clinical decision chest physiotherapy  
Calculation of the net reclassification index (NRI) (29): 
NRI (%) = (Pupevents – Pdownevents) – (Pupnonevents – Pdownnonevents) 
 
With: 
Events: the results of the lung and diaphragm US are compatible with the clinical diagnosis 
for a clinical hypothesis. 
Non Events: the results of the lung and diaphragm US are not compatible with the clinical 
diagnosis for a clinical hypothesis. 
 
Pupevents: number of «events» when the LUS results modified the chest physiotherapy 
treatment modalities divided by the total number of «events». 
Pdownevents: number of «events» when the LUS results didn’t modify the chest physiotherapy 
treatment modalities divided by the total number of «events». 
Pupnonevents: number of «non-events» when the LUS results modified the chest physiotherapy 
treatment modalities divided by the total number of «non-events». 
Pdownnonevents: number of «non-events» when the LUS results didn’t modify the chest 
physiotherapy treatment modalities divided by the total number of «non-events». 
 

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The significance test used will be the correlated proportions test (use of the properties of 
multinomial distribution). This is an asymptotic test for the hypothesis NRI=0. 
 
8.2.2. Modification of the clinical decision in CPT for each sub-group 
Calculation of the net reclassification index (NRI): 
NRI (%) = (Pupevents – Pdownevents) – (Pupnonevents – Pdownnonevents) 
- 
For the subpopulation with a CT-scan < 12h; 
- 
For eachclinicalhypotheses ; 
- 
For the level of certainty of clinical hypotheses: 
o Likert scale: strongly certain, certain, neither certain nor uncertain, uncertain, 
strongly uncertain; 
- 
For each type of patient (reason for hospitalization the most represented); 
- 
For each research center. 
8.2.3. Agreement between clinical and LUS diagnosis 
Calculation of Kappa index: 
The clinical diagnosis and the lung ultrasound allow to diagnose the following events : (the 
retained airway secretions and bronchospasm diagnoses aren’t included in the analysis as 
LUS doesn’t allow their diagnosis (LUS may only be compatible with these hypotheses): 
- T1: pneumonia/consolidation; 
- T2: atelectasis (passive or active mechanismosbtructive); 
- T3: pleural effusion; 
- T4: pulmonary edema or global interstitial syndrome; 
- T5: pneumothorax; 
- T6: reduced aeration at the most dependent parts of the lungs; 
- T7: diaphragm dysfunction (unilateral or bilateral); 
- T8: examination is inconclusive. 
 
 

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Contingency table: 
 
Lung ultrasound 
Total 
 
d
 
T1 
T2 
T3 
T4 
T5 
T6 
T7 
T8 
Clinical diagnosis 
T1 
 
 
 
 
 
 
 
 
 
T2 
 
 
 
 
 
 
 
 
 
T3 
 
 
 
 
 
 
 
 
 
T4 
 
 
 
 
 
 
 
 
 
T5 
 
 
 
 
 
 
 
 
 
T6 
 
 
 
 
 
 
 
 
 
T7 
 
 
 
 
 
 
 
 
 
T8 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
Proportion of observed agreement: 
 
Theoretical proportion of observed agreement: 
 
Kappa : 
 
The Kappa index will be calculated for the global population, the population where the 
clinical diagnosis is « strongly certain/certain » and « strongly uncertain/uncertain » and the 
population with a CT-scan < 12h. 
 
8.2.4. Proportion of cases when the chest physiotherapy protocol is 
modified following the results of the LUS: 
Calculation of proportion: Pupevents + Pupnoneventsfor all of the clinical hypothesis, for each 
clinical hypothesis and in the CT-scan <12h subpopulation. 
With a confidence interval at α=0.05. 
 
 

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8.2.5. Modification of theintensivist clinical decision 
Calculation of the net reclassification index (NRI): 
NRI (%) = (Pupevents-I – Pdownevents-I) – (Pupnonevents-I – Pdownnonevents-I) 
 
With: 
Events: the results of the lung and diaphragm US are compatible with the medical diagnosis 
of intensivistfor the patient respiratory condition for a clinical hypothesis. 
Non Events: the results of the lung and diaphragm US are not compatible with the medical 
diagnosis of intensivistfor the patient respiratory condition for a clinical hypothesis. 
 
Pupevents: number of «events» when the LUS results modified the medical treatment for the 
patient respiratory condition divided by the total number of «events». 
Pdownevents: number of «events» when the LUS results didn’t modify the medical treatment for 
the patient respiratory condition divided by the total number of «events». 
Pupnonevents: number of «non-events» when the LUS results modified the medical treatment for 
the patient respiratory condition divided by the total number of «non-events». 
Pdownnonevents: number of «non-events» when the LUS results didn’t modify the medical 
treatment for the patient respiratory condition divided by the total number of «non-events». 
9. Justification for current care 
Lung and diaphragm US is a diagnostic tool used in routine practice in ICUs by 
predominantly physicians. It has been validated as a tool to screen for pulmonary 
consolidation, atelectasis, interstitial syndrome, pleural effusion, pneumothorax and 
diaphragm dysfunction (16,30). The sensitivity and specificity of LUS are greater than those 
for chest X-ray at diagnosing these diseases in patients hospitalized in ICUs who present signs 
of acute respiratory failure (hypoxemia). LUS is non-invasive, painless and does not involve 
radiation. There are no contra-indications and no adverse side effects. We expect to that LUS 
findings may lead to a modification in decisions concerning chest physiotherapy by both the 
physiotherapist and the physicians. The choice of the chest physiotherapy and medical 
treatment protocol are made by the physiotherapist and physician, respectively, in charge of 
the patient and is based on the clinical assessments and clinical parameters available and 
according to the benefit/risk ratio. Usually, the availability of these elements varies depends 
on the clinical situation and physiotherapist and physician establish their treatment plan or 
may decide not to intervene if treatment is not indicated or could have increased patient risk. 
The addition of a lung and diaphragm US will not modify this choice based on the patient’s 

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25 
safety. Moreover, the chest physiotherapy techniques and medical treatment used are those 
conventionally used. 
10. Expectedbenefits for patients 
We expect that decisions for chest physiotherapy may be modified when the physiotherapist 
and intensivist have access to the results of lung and diaphragm US as well as the usual 
clinical and imaging parameters. 
The sensitivity and specificity of LUS is greater than that for the tools usually used by 
intensivists and physiotherapists (auscultation, chest X-ray, clinical examination) to explore 
respiratory dysfunction and to determine indications for chest physiotherapy. LUS may affect 
the management of patients with regard to chest physiotherapy by providing a more precise 
evaluation of the respiratory status and should lead to a more appropriate chest physiotherapy 
treatment. 
The expected benefit for patients is therefore that they will be given a chest physiotherapy 
protocol that is better suited to the type of respiratory dysfunction. This may include more 
optimal physiotherapy techniques for the patient, the decision not to intervene if 
physiotherapy is not indicated and more effective referral to the ICU physician in cases of 
doubt or suspicion of a condition that may warrant physician intervention. 
If the results of this investigation are positive, we plan to conduct another randomised 
controlled trial, with patients allocated to chest physiotherapy guided by lung ultrasound or 
clinical examination alone, with the objective to evaluate the impact of the use of LUS on 
respiratory function, time on mechanical ventilation, mortality rates and hospital length of 
stay). 
11. Risks for patients taking part in the study 
No additional treatment or diagnostic studies are administered as part of this study. The lung 
and diaphragm US will be performed via the trans-thoracic approach. The examination is 
therefore non-invasive, completely painless and requires no exposure to radiation. 
 
 

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13. Funding 
This study will be funded by the CHU de Dijon, the Forcilles’ hospital and the Paris St Joseph 
Hospital Network for the French centre and by the University of Technology Sydney for the 
Australian centre. Funding will cover the time spent by the physiotherapist doing the LUS-
scans, the time spent by the clinical research technician to collect the data, and by the CRA to 
monitor the study and take part in the statistical analysis. 
14. Data recording in the Case Report Form 
All of the data will be recorded in an e-CRF (https://projectredcap.org) and will be available 
for each investigator. All data will be anonymised. 
15. Ethical and regulatory aspects 
15.1. 
Information to patients 
During the pre-inclusion visit (at the onset of the inclusion criteria) the critical care physician 
will verbally inform the patient about the aims of the study, and the patient will also be given 
an explanation sheet. The patient’s consent to take part in the study will be collected and 
recorded in the patient’s medical record. The explanation will be repeated by the investigator 
(physiotherapist) at the time of the LUS. All of the examinations are part of the usual 
management of such patients. The research will be managed by the Paris St Joseph Hospital 
Network for French centres and Ethics committee of St Vincent’s Hospital for the Australian 
centres. The information on the research will be provided to the patient (cf. annexe 5a) or, if 
this is impossible because of the emergency situation, to a member of the patient’s family (cf. 
annexe 5b). If a patient could not be informed and could not sign the consent form for this 
research, and/or if a patient was included with the consent of a family member, the patient 
will be informed and will be invited to continue to participate in the research as soon as he/she 
has recovered his/her cognitive abilities. 
15.2. 
Need to submit the study for approval by an ethics committee 
Yes. 
 
 

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Le Neindre A, Mongodi S, Philippart F, Bouhemad B. Thoracic ultrasound: Potential 
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physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69–76.  
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Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, et 
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Lichtenstein D, Mézière G, Biderman P, Gepner A, Barré O. The Comet-tail Artifact. 
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critical care practice. Crit Care. 2007 Feb 16;11(1):205.  
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follow-up of community-acquired pneumonia. Eur J Intern Med. 2012 Jul;23(5):391–7.  
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Bourcier J-E, Paquet J, Seinger M, Gallard E, Redonnet J-P, Cheddadi F, et al. 
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26.  
Soummer A, Perbet S, Brisson H, Arbelot C, Constantin J-M, Lu Q, et al. Ultrasound 
assessment of lung aeration loss during a successful weaning trial predicts postextubation 
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Lerolle N, Guérot E, Dimassi S, Zegdi R, Faisy C, Fagon J-Y, et al. Ultrasonographic 
diagnostic criterion for severe diaphragmatic dysfunction after cardiac surgery. Chest. 2009 
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Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, et al. 
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17. Annexes 
Annexe 1: Indications for chest physiotherapy in acute care patient 
 
Annexe 2a: Clinical prediction model by physiotherapist 
 
Annexe 2b: Chest physiotherapy treatment modalities 
 
Annexe 3a: Lung and diaphragm ultrasound procedures 
 
Annexe 3b: LUS semiology 
 
Annexe 4: LUS-scan report 
 
Annexe 5a: Information sheet for patients 
 
Annexe 5b: Information sheet for a patient’s relatives 
 
 

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Annexe 1: Indication for chest physiotherapy in acute care patient 
 
The main potential indication for chest physiotherapy in acute care patient is hypoxemia. 
 
Hypoxemia is defined here by SpO2/FiO2< 315 (15) 
 
FiO2 in non-ventilated patient is estimated according to the table below(31): 
 
 

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Annexe 2a: Clinical hypothesis model by physiotherapist 
Clinical examination is compatible with retained airway secretions 
 
Auscultation 
Rhonchi, crackles, wheeze 
Palpation 
Palpable chest wall fremitus 
Cough/Suction 
Producing sputum 
Clinical examination is compatible with bronchospasm 
Chest X-rays 
“Hyperinflated lungs” 
 
Auscultation 
Expiratory Wheeze 
 
Inspection 
Prolonged expiratory phase 
Accessory inspiratory muscles 
use 
Clinical examination is compatible with pneumonia pattern 
Chest X-rays 
Lobar consolidation or 
interstitial opacities 
+/- airbronchogram 
No volume loss 
Auscultation 
Fine crackles 
Decreased or abolished 
vesicular sound 
Bronchial breath sound 
Palpation/percussion 
Dullness 
Increased vocal fremitus 
Inspection 
+/- focal decreased chest 
mobility 
Clinical examination is compatible with atelectasis pattern (passive or obstructiveactive 
mechanism) 
Chest X-rays 
Lobar consolidation 
+/- airbronchogram 
Volume loss 
Auscultation 
Abolished vesicular sound 
Palpation/percussion 
Dullness 
Increased vocal fremitus 
Inspection 
+/- focal abolished chest 
mobility 
Clinical examination is compatible with pleural effusion (PE)/(+/- passive 
atelectasis) 
Chest X-rays 
Blunting of the costophrenic 
and/orcardiophrenic angles 
Meniscus 
Mediastinal shift (large PE) 
Auscultation 
Abolished vesicular sound 
Palpation/percussion 
Dullness 
Decreased vocal fremitus 
Pleural rub sound 
Inspection 
+/- focal abolished chest 
mobility on the side of the PE 
Clinical examination is compatible with acute pulmonary oedema(cardiogenic or not) 
Chest X-rays 
Cephalization of pulmonary 
vessels 
Kerley B lines 
Peri-bronchial cuffing 
« Bat wing » pattern 
Auscultation 
Bilateral and diffuse fine 
crackles 
+/- Wheeze 
Palpation/percussion 
Palpable chest wall fremitus 
Inspection 
Inspiratory dyspnea 
Clinical examination is compatible with pneumothorax 
Chest X-rays 
Air without lung markings in 
the least dependant part of 
the chest unless loculated 
Auscultation 
Abolished vesicular sound 
Palpation/percussion 
Hyper tympanic 
Abolished vocal fremitus 
Inspection 
Decreased chest mobility 
Clinical examination is compatible with reduced of aeration at the most 
dependent parts of the lungs 
Chest X-rays 
Lobar consolidation or 
interstitial opacities at the 
inferior parts of the lungs 
Auscultation 
Decreased or abolished 
vesicular sound at the lung 
bases 
Palpation/percussion 
Dullness at the lung bases 
Inspection 
Decreased chest mobility 
Clinical examination is compatible with diaphragm dysfunction 
Chest X-rays 
Elevation of hemidiaphragm 
cupola 
Auscultation 
Decreased or abolished of 
basal vesicular sound 
 
Inspection 
Decreased chest mobility 
Thoracic inspiration 
Paradoxical respiration 
The bilateral or unilateral nature of diaphragm dysfunction is defined by the unilateral or bilateral nature of the previous signs. 
Clinical examination is inconclusive 
No syndrome clearly defined 
 
 

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Annexe 2b: Chest physiotherapy treatment modalities 
Clinical hypothesis 
Chest physiotherapy treatment 
Retained airway secretions 
Airway clearance techniques 
(Rib cage compressions, manual assisted cough, manual lung 
hyperinflation, ventilator hyperinflation, MIE, ETS/NTS, patient 
positioning) 
Bronchospasm 
Bronchodilators inhalation 
Pneumonia pattern 
 
Unilateral 
Bilateral 
Non 
intubated 
Laterocubitus (diseased lung 
uppermost) + NIV/CPAP 
Seated position + 
NIV/CPAP 
Intubated 
Laterocubitus (diseased lung 
uppermost) + PEEP 
Seated position, prone 
position + PEEP 
Obstructive Aatelectasis 
pattern 
 
Lobar 
Entire lung 
Non 
intubated 
Laterocubitus (diseased lung uppermost) + NIV 
Intubated 
Laterocubitus (diseased lung 
uppermost) + 
hyperinflation/PEEP 
Refer to medical staff 
Pleural effusion/Passive 
atelectasis 
 
Unilateral 
Bilateral 
First, refer to medical staff 
Non 
intubated 
Laterocubitus (diseased lung 
uppermost) + NIV/CPAP 
Seated position + 
NIV/CPAP 
Intubated 
Laterocubitus(diseased lung 
uppermost)+ PEEP 
Seated position + 
PEEP 
Acute pulmonary oedema 
 
Refer to medical staff 
Non 
intubated 
Seated position + NIV 
Intubated 
Seated position 
Pneumothorax 
Refer to medical staff 
Reduced aeration at 
dependent parts of the lungs 
Seated or upright position, mobilization out of bed 
Diaphragm dysfunction 
Seated position, recovery monitoring, IMT 
Clinical examination is 
inconclusive 
Refer to medical staff 
MIE = MechanicalInsuflation-Exsuflation ; ETS/NTS = Endotracheal/Nasotrachealsuction ; NIV = Noninvasive ventilation ; 
CPAP = Continous positive airway pressure ; PEEP = Positive end expiratory pressure ; IMT = Inspiratory muscle training 
 
 

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Annexe 3a: Lung and diaphragm ultrasound procedures (16) 
Lung assessment 
 
PSL: Parasternal line; AAL: Anterior axillary line; PAL: Posterior axillary line 
Scanning procedure 
Interstitial syndrome: Investigation is performed at the anterior and lateral thoracic areas. A positive region is 
defined by the presence of three or more B-lines in a longitudinal plane between two ribs, and a positive exam 
suggests the presence of two or more positive regions. A convex probe is used. 
Consolidation: Examination begins with the lung area of interest (refer to clinical assessment) and may involve 
the entire lung if necessary. A convex probe is used. 
Pneumothorax: In the supine patient, the sonographic technique consists of exploration of the least 
gravitationally dependent areas progressing laterally. A convex or a linear probe may be used. 
Pleural effusion: In the supine patient, the ultrasound probe is placed in the postero-inferior area in the 
transverse view. The maximum distance between the parietal and visceral pleura (PLD) is measured 3 cm above 
the inferior pole of the lung at the end of expiration. 
Diaphragm assessment – excursion and thickeness(If ventilated patient use PSV mode with PS = 7 and PEEP =  0) 
 
Diaphragm excursion: Anterior subcostal approach: the probe is placed between the anterior axillary line and 
the mid-clavicular line. B-mode is initially used to determine the best approach and select the exploration line. 
After the diaphragm is identified, excursion measurements are performed in M-mode: the diaphragm moves 
toward the probe during inspiration and away from it during expiration. The distance between the end-inspiration 
and end-expiration points defines the diaphragm excursion. A diaphragm excursion< 2.5 cm (Lerolle Chest, 
2009) indicates a diaphragm dysfunction. 
 
 
 
Diaphragm thickening: the probe is placed in an intercostal space between the mid-axillary line and the anterior 
axillary line, 0.5 cm to 2 cm below the costo-diaphragmatic sinus. In B-mode, the diaphragm is observed as a 
structure made of three distinct layers: a non-echogenic central layer bordered by two echogenic layers. The 
diaphragm thickening fraction (DTF) measurement is obtained in B-mode using the following formula: DTF (%) 
= [(end-inspiration thickness – end-expiration thickness)/(end-expiration thickness) x 100]. A DTF < 25% 
indicates a diaphragm dysfunction. 

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Annexe 3b: LUS Semiology 
NORMAL PATTERN 
A. Seashore sign (left, M-mode): Tissues above the pleural line are 
motionless and generate horizontal lines (sea). Below the pleural 
line, structures (i.e., lung and visceral pleura) are in motion and 
generate a sandy pattern. Bat sign (right, B-mode): In the 
intercostal space, the shape of the superior and inferior ribs and 
pleural line (i.e., hyperechoic line) appear in the shape of a bat. A-
lines (right, B-mode): Horizontal repetition artifacts of the pleural 
line (big arrows) that indicate the presence of lung aeration. 
INTERSTITIAL SYNDROME 
B.B-lines: Comet-tail artifacts (arrows) that arise from the pleural lines 
and erase A-lines are nearly always long and always move with lung 
sliding. 
 
 
C. PLEURAL EFFUSION 
Pleural effusion appears as dependent and anechoic (ie, free of echoes) 
structures. Pleural effusion occurs between the diaphragm and the pleura, 
and conducts ultrasounds, C. Sinusoid sign (left, M-mode): During 
inspiration, the visceral pleura moves toward the parietal pleura; this sign 
indicates a free pleural effusion. Quad sign (right, B-mode): The visceral 
pleural, parietal pleura and shadows of the ribs form a quad; this sign 
indicates a pleural effusion in an intercostal space. 
Quantification of pleural effusion: patient in supine with mild trunk 
elevation at 15°. Ultrasound probe is moved in cranial direction in 
posterior axillary line. The transverse section perpendicular to the body 
axis is obtained with pleural separation visible as an anechoic or 
hypoechoic layer between two pleural layers. The maximal distance 
between parietal and visceral pleura(Sep) is measured off line at the lung 
base after freezing the image in end-expiration. 
 
CONSOLIDATION 
D. Shred sign (B-mode): A deep
boundary (arrow) with a shredded 
appearance indicates a partial lobar 
consolidation. Note the presence of 
an air bronchogram (Br). 
CONSOLIDATION 
E. Tissue-like sign (B-mode) A
tissue-like pattern arising from the 
pleural line (or visceral pleura) of a 
complete lobar consolidation. 
PNEUMOTHORAX 
Lung point (M-mode): Refers to the 
absence of any sliding or moving B-
lines at the physical locations where 
the transition into an area of sliding 
occurs. 
Stratospheric 
sign 
(M 
mode): absence of pleural sliding 
(P). 
P = pleural line; Rs = superiorrib; Ri = inferiorrib; Pp = parietal pleura; Pv = visceral pleura; Pe = pleural 
effusion; C =lung consolidation; D = diaphragm; Br = air bronchogram. 

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Annexe 4: Lung and diaphragm ultrasound scan report 
 
VENTILATOR SETTINGS (Surround the mode and fill the settings at the moment of LUS examination) 
Mode 
ACV 
SIMV 
PCV 
PSV 
NIV 
Spontaneously 
Breathing 
Settings 
Tidal volume =                  PEEP = 
PS =          PEEP = 
 
PNEUMOTHORAX 
Right 
Present 
Absent 
Left 
Present 
Absent 
If present, locate the lung point in the diagram below (place an « X ») 
 
LUNG AERATION 
 
 
LAT 
ANT 
ANT 
LAT 
 
 
Superior 
POST 
 
 
 
 
POST 
Superior 
Inferior 
 
 
 
 
 
 
Inferior 
Indicate level of lung aeration (0, 1, 2, 3) in the above diagram 
LUS score =         /36 
When lung consolidation is present, indicate the appropriate letter(s)(in the above diagram, following the « 3 ») : 
a. 
Deep limiw ith Shred sign 
b. 
Deep limit well defined 
c. 
Dynamic air bronchogram 
d. 
Static air bronchogram 
e. 
Punctiform air bronchogram 
f. 
Linear air bronchogram 
g. 
Fluid bronchogram 
h. 
Vascular pattern 
 
PLEURAL EFFUSION 
 
Right 
Left 
PLD (cm) 
 
 
Pattern 
Anechoic 
Heterogeneously 
echogenic 
Homogeneously
echogenic 
Septated 
Anechoic 
Heterogeneously
echogenic 
Homogeneously
echogenic 
Septated 
 
DIAPHRAGM 
 
Right 
Left 
tdi/tde (cm) 
 
 
 
 
DTF (%) 
 
 
EXC (cm) 
 
 
 
ULTRASOUND DIAGNOSTIC 
Scan quality: 
Good 
Poor 
 
Sonographer: 
Normal 
Pneumothorax (L), (R) or Both 
Alveolar-interstitial syndrome 
Focal 
Diffuse 
Homogeneous 
Heterogeneous 
Moderate 
Severe 
Lung consolidation 
Pneumonia pattern 
Atelectasis pattern 
Unilateral (L )or (R) 
Bilateral 
Obstructive 
Passive 
Pleural effusion 
Unilateral (L) or  (R) 
Bilateral 
Transudative pattern 
Exsudative pattern 
Diaphragm dysfunction 
Loss of aeration in the most dependent 
parts of the lungs 
Unilateral (L) or (R) 
Bilateral 
No conclusion 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 
Pleural sliding 
Lung pulse 

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Annexe 5a: Information sheet for patients 
Information sheet for adults taking part in research aiming to evaluate usual care entitled: 
«Evaluation of the impact of lung and diaphragm US findings on clinical decisions for chest 
physiotherapy in patients hospitalized in Intensive Care Unit» 
 
Sir, Madam, 
Dr………………….. , principal investigator, is inviting you to take part in this research. 
Your decision concerning your participation is made of your own free will. 
Would you please read the information below very carefully and ask any questions you wish to. You 
make take as much time as you need to think about taking part or not in this research before reaching 
your decision. 
Context, objectives and procedure of this research 
You are hospitalized in an Intensive Care Unit. Your state of health is associated with breathing 
difficulties which require chest physiotherapy. The aim of the physiotherapy is to improve your 
breathing. The physiotherapist uses different techniques depending on the specific problems you suffer 
from. To identify your specific problem he/she will examine you, using a stethoscope to listen to your 
lungs and refer to the results of the chest x-ray and biological examinations. In this research, we wish 
to study the impact of including a lung and diaphragm ultrasound scan to know if this examination 
could modify the physiotherapist’s choices with regard to your treatment thanks to the new 
information it may provide.  This LUS-scan will be done by a physiotherapist. 
This examination is painless, non-invasive and is perfectly safe. It will be done by a physiotherapist 
once only and before the respiratory physiotherapy session. An ultrasound scanner with a transducer 
will be used and a gel will be put on your skin. The examination takes about 15mn.  
Constraints in this research 
There are no constraints apart from your participation in the research. 
Possible adverse effects 
As your participation in this research does not involve any treatment other that those currently 
recommended or any modification of the classical management of patients in critical care, no adverse 
effects are foreseen. 
- 
No additional treatment will be given 
- 
No additional blood samples will be taken. 
The ultrasonography will be done using a transthoracic approach, which simply means the 
transducer will be placed on your chest. The examination is therefore non-invasive, completely 
painless and does not involve exposure to X-rays. 
Your participation in this research will involve no additional cost for you. 
 
 

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38 
Ethical and legal aspects 
This research was approved by the CPP Ile de France II on……… 2016. 
Confidentiality 
In the context of this research proposed by Dr............................. personal data will be processed to 
allow analysis of the results of the research. 
To this end, your medical information will be sent to the different co-investigators. This information 
will be identified by a code number. The information may also, in conditions to ensure its 
confidentiality, be sent to the French healthcare authorities. In compliance with the requirements of the 
CNIL (law relative to computerized information, files and freedom), you have the right to read and 
rectify this information. You also have the right to oppose the transmission of information covered by 
medical confidentiality that may be used and processed in the context of this research. 
You also have the right of access either directly or through a physician of your choice to all of your 
medical information in accordance with article L. 1111-7 of the Public Health Code. These right scan 
be exercised through the physician who is following you in the context of the research and who knows 
your identity. 
 
 
Your decision to take part in this research is made of your own free will. 
You can refuse to take part or withdraw your consent at any time without explanation. Refusal 
to take part or withdrawal of your consent will have no impact on the care you receive. 
 
Do you have any questions? 
 
Dr ________________________ (tel ___________) is available to answer any questions you feel 
necessary both before and during the research. 
 
 

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Annexe 5b Information sheet for a patient’s relative 
Information sheet for adults taking part in research aiming to evaluate usual care entitled: 
«Evaluation of the impact of lung and diaphragm US findings on clinical decisions for chest 
physiotherapy in patients hospitalized in Intensive Care Units» 
 
Sir, Madam, 
As your relative’s condition makes it impossible for him/her to be given or to understand the 
information for this research, we are giving to you this information and the invitation for Ms. / Mr. 
(delete as necessary) (family name, first name)………………………………….. to take part in the 
study presented below, which is under the responsibility of Dr……………..principal investigator. 
Your decision concerning this participation is made of your own free will. 
Would you please read the information below very carefully and ask any questions you wish to. You 
make take as much time as you need before reaching your decision as to whether your relative should 
take part or not in this research. 
Context, objectives and procedure of this research 
Your relative is hospitalized in an Intensive Care Unit. His/her state of health is associated with 
breathing difficulties which require chest physiotherapy. The aim of the physiotherapy is to improve 
his/her breathing. The physiotherapist uses different techniques depending on the specific problems 
he/she suffers from. To identify his/her specific problem the physiotherapist will examine your relative 
using a stethoscope to listen to his/her lungs and refer to the results of the chest x-ray and biological 
examinations. In this research, we wish to study the impact of including a lung and diaphragm 
ultrasound scan to know if this examination could modify the physiotherapist’s choices with regard to 
your relative’s treatment thanks to the new information it may provide.  This LUS-scan will be done 
by a physiotherapist. 
This examination is painless, non-invasive and is perfectly safe. It will be done by a physiotherapist 
once only and before the respiratory physiotherapy session. An ultrasound scanner with a transducer 
will be used and a gel will be put on your relative’s skin. The examination takes about 15mn.  
Constraints in this research 
There are no constraints apart from your relative’s participation in the research. 
Possible adverse effects 
As participation in this research does not involve any treatment other that those currently 
recommended or any modification of the classical management of patients in critical care, no adverse 
effects are foreseen. 
- 
No additional treatment will be given 
- 
No additional blood samples will be taken. 

V06-20-2017 
 
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40 
The ultrasonography will be done using a transthoracic approach, which simply means the 
transducer will be placed on his/her chest. The examination is therefore non-invasive, completely 
painless and does not involve exposure to X-rays. 
Your relative’s participation in this research will involve no additional cost for him/her. 
Ethical and legal aspects 
This research was approved by the CPP Ile de France II on……… 2017. 
Confidentiality 
In the context of this research proposed by Dr............................... your relative’s personal data will be 
processed to allow analysis of the results of the research. 
To this end, his/her medical information will be sent to the different co-investigators. This information 
will be identified by a code number. The information may also, in conditions to ensure its 
confidentiality, be sent to the French healthcare authorities. In compliance with the requirements of the 
CNIL (law relative to computerized information, files and freedom), your relative has the right to read 
and rectify this information. He/she also has the right to oppose the transmission of information 
covered by medical confidentiality that may be used and processed in the context of this research. 
Your relative also has the right of access either directly or through a physician of his/her choice to all 
of his/her medical information in accordance with article L. 1111-7 of the Public Health Code. These 
right scan be exercised through the physician who is following him/her in the context of the research 
and who knows his/her identity. 
 
 
Your decision for your relative to take part in this research is made of your own free will. 
You can refuse this participation or withdraw your consent at any time without explanation. 
Refusal to take part or withdrawal of your consent will have no impact on the care your relative 
receives. 
 
Do you have any questions? 
 
Dr ________________________ (tel ___________) is available to answer any questions you feel 
necessary both before and during the research.