Clinical trial NCT02613832: Applicability of Techniques of Lung Expansion
Official title: Immediate Effect of Expiratory Positive Airway Pressure and Breath Stacking in Non-cooperative Patients Detected by Electrical Impedance Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Noncooperative patients
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

Detailed description: The survival of patients with lesions in the Central Nervous System is usually accompanied by physical and mental permanents sequelae. This impairment of cognitive status associated with motor injury favors prolonged restriction of these patients to the bed, which may contribute to the emergence of other health damages. In the clinical practice, lung expansion techniques has been used as a prophylaxis and treatment of respiratory conditions that involve volumetric reductions. However, the deficit of awareness and cooperation difficult the use of several therapeutic resources. There are few interventions that could be proposed due to no need the collaboration to be performed, such as Breath Stacking technique (BS) and Expiratory Positive Airway Pressure (EPAP). The BS is characterized by execution of inspiratory cycles through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches values approximate to maximum inspiratory capacity. While in the EPAP, alveolar pressure is elevated to breath against a expiratory flow resistance generated by a spring load valve. The effects on lung volume promoted BS and EPAP can be safely measured using an electrical impedance tomography (EIT). This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. The effects on lung volume promoted BS and EPAP can be safely measured using an EIT monitor. This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. Until this moment, there is not description about the effect of lung expansion techniques on regional lung parameters.

Eligibility criteria: Inclusion criteria:

1. Patients undergoing neurosurgery restricted to bed for more than 14 days;
2. Aged between 18 and 65 years;
3. Glasgow Coma Scale \< 10 points;
4. Breathing spontaneously through the tracheostomy tube;
5. No respiratory infection;
6. Chest circumference between 88 and 98 centimeters;

Exclusion criteria:

1. Presence of chronic lung diseases;
2. Chest deformity;
3. Rib fracture;
4. Asymmetrical chest expansion;
5. Abdomen distension;
6. Spasticity in any hemisphere with Ashworth Scale score more than 2 points for upper limbs;
7. Uncoordinated movements of the limbs;
8. Cardiorespiratory instability (heart rate \< 60 or \> 120 bpm; respiratory rate \> 35 ipm; mean arterial pressure \< 60 mmHg or \> 120 mmHg; oxygen saturation \< 90%).

Primary outcomes:
measure: Regional Lung Aeration
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
Secondary outcomes:
measure: Regional Lung Ventilation
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
measure: Heart Rate
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
measure: Mean Arterial Pressure
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
measure: Respiratory Rate
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
measure: Periferic Saturation of Oxygen
timeFrame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital of Clinics of the Federal University of Pernambuco
state: PE - Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Caio César A Morais, Master
role: STUDY_CHAIR
affiliation: Universidade Federal de Pernambuco
name: Shirley L Campos, PHD
role: STUDY_CHAIR
References:
citation: Bayford R, Tizzard A. Bioimpedance imaging: an overview of potential clinical applications. Analyst. 2012 Oct 21;137(20):4635-43. doi: 10.1039/c2an35874c.
citation: Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
citation: Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
citation: Baker WL, Lamb VJ, Marini JJ. Breath-stacking increases the depth and duration of chest expansion by incentive spirometry. Am Rev Respir Dis. 1990 Feb;141(2):343-6. doi: 10.1164/ajrccm/141.2.343.
citation: Morais CC, Campos SL, Lima CS, Monte LJ, Bandeira MCP, Brandao DC, Costa EL, Aliverti A, Amato MB, Andrade AD. Acute Effects of Lung Expansion Maneuvers in Comatose Subjects With Prolonged Bed Rest. Respir Care. 2021 Feb;66(2):240-247. doi: 10.4187/respcare.07535. Epub 2020 Oct 6.