Effect of a Double Trunk Mask Associated to Nasal Prongs During a High Flow Oxygenation Method
Phase: NA
Conditions: Oxygen Inhalation Therapy
Sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
Clinical Intervention Study 
Protocol  
 
 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
FULL PROTOCOL TITLE 
 
Effect of a Modified Oxygen Mask Associated to Nasal Prongs During 
High Flow Oxygenation in ICU patient: a cross over study 
 
Principal Investigator:   
 
Duprez Frédéric,Msc, Epicura Hornu, Condorcet Tournai 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
 
 
 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
STUDY TEAM ROSTER  
Mr Arnaud Bruynel NT Msc ICU Hospital TIVOLI 00 32 64 27 61 11 ICU Hospital 
TIVOLI 00 32 64 27 61 11   
arnaudbruyneel8@gmail.com 
Mr Duprez Frédéric PT Msc Hospital Epicura Hornu 003265713643 
frederic.duprez@condorcet.be 
Mr Cuvelier Gregory PT Msc Condorcet Laboratory Tourna Belgium 003269452940 
gregory.cuvelier@condorcet.be 
Mr Reychler Gregory PT PhD IREC, Cliniques Universitaires Saint Luc Bruxelles 
00327641111  gregory.reychler@condorcet.be 
Dr Mashayekhi Sharam MD (Head chief of ICU ) Hospital Epicura Hornu 
003265713643 and ICU Hospital TIVOLI 00 32 64 27 61 11 
sharam.mashayekhi@epicura.be 
 
PARTICIPATING STUDY SITES 
Hospital Epicura Hornu 63 rue de Mons 7301 Hornu Belgique 
Hospital Tivoli Avenue Max Buset 34, 7100 La Louvière Belgique 
 
PRÉCIS  
 
Study Title  
Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow 
Oxygenation in ICU patient: a cross over study 
Objectives  
The primary endpoint was the change of PaO2. 
The secondary endpoint was the change of PaCO2, pH and patient respiratory comfort 
                      Design and Outcomes   
This is a single-center, randomized, blind investigator, 2-way crossover study design 
to test the efficacity of a special mask (DTM) add above nasal prongs during High 
Flow Oxygenation 
 
 
 
 
 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
 
 
 
 
 
 
Hypoxia 
PaO2/FiO2 < 300 
Rf > 25 CPM 
PaCO2 < 45 mm Hg 
 
Write patient (or family) 
Consent 
 
                                                    Nasal Prongs with High 
                                                 Flow Oxygenation to 
                                                  obtain SPO2 > 90% 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1 
 
 
Arterial gazometry  
> 20 and 60 min 
+ Dyspnea MRC 
 
DTM + Nasal 
Prongs High flow 
O2
Remove only DTM  
Arterial gazometry  
> 20 and 60 min 
+ Dyspnea MRC 
 
Arterial gazometry  
> 20 and 60 min 
+ Dyspnea MRC 
 
If SpO2 < 90% or 
signs of dramatic 
dyspnea, withdrawal 
DTM + medical 
advice

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
 
 
 
 
 
Interventions and Duration  
Sequence (Figure 1): The patient should be placed in semi-seated (position at 45 °) 
Patient will be oxygenated with high-flow nasal cannula (HFNC). Fraction delivered in 
Oxygen and flow rate will be adjusted to obtain a Saturation in oxygen > at 90%. 
1. Arterial gazometry will be taken after 20 and 60 minutes with HFNC. 
2. The clinician will associate the Double Trunk Mask (DTM) with the same parameters 
of the high-flow nasal cannula. Arterial gazometry will be performed after 20 and 60 
minutes after placement of DTM. 
3. After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 
minutes 
 
Sample Size and Population  
Enrolled participants had severe hypoxia being treated at Intensive Care Unit  
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
The experimental treatment will result of an increase of PaO2 when the special mask 
will be adding above nasal prongs compared with no mask addition. 
1.2 
Secondary Objectives 
The Secondary objectives is the change of PaCO2, pH and patient respiratory comfort with 
the mask addition above prongs 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Oxygen therapy is the main treatment during Hypoxia. In this case, arterial Pressure 
Oxygenation should be maintained within strict limits. High Flow Oxygenation 
system can be used to administer Oxygen therapy (FDO2). In this case, high 
inspiratory flow decreases fraction delivered in oxygen. The addition of a special 
mask (Double Trunk Mask) can limits the fraction delivered in oxygen decrease. 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
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2.2 
Study Rationale 
Few studies emphases the decreases of FDO2 during inspiratory flow increases. 
 
Studies: 
Hnatiuk OW, Moores LK, Thompson JC, Jones MD. Delivery of high concentrations 
of inspired oxygen via Tusk mask. Crit Care Med. 1998 Jun;26(6):1032-5.   PubMed 
ID: 9635651 
 
Chechani V, Scott G, Burnham B, Knight L. Modification of an aerosol mask to 
provide high concentrations of oxygen in the inspired air. Comparison to a 
nonrebreathing mask. Chest. 1991 Dec;100(6):1582-5.   PubMed ID: 1959399  
 
Duprez F. Effet du pattern respiratoire sur la FiO2 au cours de l’oxygénothérapie 
Revue des Maladies Respiratoires. Volume 32, Supplement, January 2015, Page A81 
 
The intervention has been chosen because in our experience, double trunk mask is 
currently use to fight FDO2 decrease during inspiratory flow increase. 
 
3. STUDY DESIGN 
 
This is a single-center, randomized, blind investigator, 2-way crossover study design. 
Enrolled participants had severe hypoxia being treated at Intensive Care Unit 
associated with a hospital in Hornu (Epicura) and hospital Tivoli. 
The study consisted of two intervention periods separated by a washout period of 20 
minutes. (Figure 1) 
The objective of the study is to determine whether adjunctive mask of our design 
(Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen 
(PaO2) diagnosed with severe hypoxia (See figure 1). 
The protocol and informed consent documents were reviewed and approved by a 
recognized ethics review board at the study facility. The study was performed in 
accordance with the Declaration of Helsinki. 
 
 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
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4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria 
• At least 18 years of age 
• Diagnosed with severe Hypoxia  (PaO2/FiO2 < 300 mm Hg) 
• Dyspnea with severe rest at stake accessory muscles of respiration 
• Respiratory rate (RR) ≥ 25 CPM 
• PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic 
instability 
• Glasgow Coma Scale ≥ 12/15 
• Written consent.  
• Participants were also required to have a sufficient level of education to 
understand study procedures and be able to communicate with site personnel. 
4.2 
Exclusion Criteria 
• Hypercapnia (> 45 mm Hg with respiratory acidosis) 
• Cardiogenic pulmonary edema 
• COPD 
• Pulmonary fibrosis 
• Hypoventilation obesity syndrome 
• Arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 
gamma/kg/minute 
• Deterioration of awareness (Glasgow scale < or = 12) 
• Acute confusional state. 
 
Participants were randomized in a 1:1 ratio to receive either (CHFONP) classical 
High Flow Oxygenation with nasal prongs (20 minutes) or CHFNOP with an 
adjunctive of a DTM. 
4.3 
Study Enrollment Procedures  
Enrolled participants had severe hypoxia being treated at Intensive Care Unit 
associated with a hospital in Hornu (Epicura).and Tivoli Hospital. 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
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5. STUDY INTERVENTIONS  
 
Interventions, Administration, and Duration  
 
Sequence (Figure 1): The patient should be placed in semi-seated (position at 45 °) 
Patient will be oxygenated with high-flow nasal cannula (HFNC). Fraction delivered 
in Oxygen and flow rate will be adjusted to obtain a Saturation in oxygen > at 90%. 
1. Arterial gazometry will be taken after 20 and 60 minutes with HFNC. 
2. The clinician will associate the Double Trunk Mask (DTM) with the same 
parameters 
of the high-flow nasal cannula. Arterial gazometry will be performed after 20 and 60 
minutes after placement of DTM. 
3. After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 
minutes  

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
Consenting Procedure 
The protocol and informed consent documents were reviewed and approved by a 
recognized ethics review board at the study facility. The study was performed in 
accordance with the Declaration of Helsinki. 
Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrolled participants had severe hypoxia being treated at Intensive Care Unit 
associated with a hospital in Hornu (Epicura).and Tivoli Hospital. 
Baseline Assessments 
For participants who have successfully been screened for eligibility and are enrolled 
into the study, baseline assessments are performed against which to measure the 
study outcome: 
Age, Weight, Height, arterial pressure (S/D/M), Cardiac frequency, respiratory 
frequency, PaO2, PaCO2, pH, MRC dyspnea, MRC Comfort, Glasgow Coma Scale. 
Blinding 
Data’s should be evaluated in blind by an independent assessor 
 
Adverse Event Assessment 
 
Safety was assessed by the number of participants with adverse events (AEs). AEs 
were collected by systematic assessment using terms from the Medical Dictionary for 
Regulatory Activities (MedDRA), version 11.1 in participants who received one or 
more doses of intervention. Adverse events during washout were not collected. 
 
6. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
Cross over design is the most appropriate to compare one intervention in the same 
groups of persons 
Length of washout chosen is 30 to 60 minutes because after this period, following 
parameters are stabilized after intervention (PaO2, PaCO2, pH)   
9.2 
Outcomes  
Discuss how the outcomes will be analyzed. Describe whether the documentation of 
an outcome will be reviewed and adjudicated by a committee, how quickly the 
committee will perform the adjudication, and whether the committee will be masked 

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Effect of a Modified Oxygen Mask Associated to Nasal Prongs During High Flow Oxygenation 
24 October 2017 
to the participant’s intervention group assignment.  
Primary Outcome   
PaO2 is the primary outcomes observed. PaO2 is the principal parameters observed 
Secondary Outcomes   
PaCO2, pH, MRC dyspnea and comfort 
9.3 
Data Analyses  
All participants who received this intervention and completed two phases of study 
were included in the efficacy analysis.  
A sample size of 15 participants was needed to provide 90% power to detect a 10 mm 
Hg difference in PaO2. ANOVA for repeated measures followed by a post hoc test 
were used to compare the difference between participants receiving (high-flow nasal 
cannula + DTM) and with high-flow nasal cannula alone. 
The test was performed with a significance level of 0.05 (two-sided). Statistical 
analyses were carried out using SigmaPlot software version 11.0 (Systat Software 
Inc. UK). 
Note: In accordance with NIH policy, if data from prior studies do not negate 
strongly the existence of significant differences of clinical or public health 
importance in the intervention effect between gender and racial/ethnic subgroups, a 
statement should be included noting that a valid analysis of the intervention effect 
will be performed in these subgroups. If data from prior studies do not strongly 
support the existence of significant differences in the intervention effect between 
subgroups, then the analyses need not have high statistical power for detecting 
clinically meaningful differences.  
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
For maintaining confidentiality of participant records, all data’s will be recorded 
directly on the CRFs (ICH Guidelines, E6.4.9)