The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU

Study Overview
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Brief Summary
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The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.

Official Title
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The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: Mechanical insufflation-exsufflation
* Other: Standard Respiratory Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Admission to the ICU Length of mechanical ventilation > 24 hours Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg. Exclusion Criteria: Patients with primary neuromuscular disease. Patients in exclusive paliative care. Patients with contraindications to the use of mechanical insufflation- Exsufflation device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mechanically ventilated patients will be randomized to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or to receive standard respiratory physiotherapy without the use of a mechanical insufflation-exsufflation device (control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist) | Other: Mechanical insufflation-exsufflation<br>* The mechanical insufflation-exsufflation device will be connected in the orotracheal tube. Four series of insufflation-exsufflation will be conducted. Each serie will be composed by 10 cycles of alternated insufflation (40 cmH2O) and exsufflation (- 40 cmH2O).<br>* Other names: CoughAssist;|
| Active Comparator: Control Group<br>Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device. | Other: Standard Respiratory Physiotherapy<br>* Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of aspirated secretion | Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy). | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static lung compliance | Single measure of the static lung compliance in mL/cm H2O | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | 
| Airway resistance | Single measure of the airway resistance in cm H2O/L/s | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Failure, Mechanical Ventilation, Mechanical insufflation-exsufflation, Airway mucus clearance