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

Not Applicable

• Conditions: Respiratory Failure
• Interventions: Other: Mechanical insufflation-exsufflation; Other: Standard Respiratory Physiotherapy

• Registration Number: NCT03178565
• Lead Sponsor: Hospital Moinhos de Vento

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-04-21
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-03
• Last Update Submitted: 2017-06-03
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

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Exclusion Criteria

• Patients with primary neuromuscular disease.
• Patients in exclusive paliative care.
• Patients with contraindications to the use of mechanical insufflation- Exsufflation device.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mechanical insufflation-exsufflation	Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist)
Control Group	Standard Respiratory Physiotherapy	Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil