Mechanical insufflation-exsufflation (Cough Assist) in Critically Ill Adults: A randomized controlled trial

Recruiting

• Conditions: airway clearance - mucociliary clearance; respiratory secretion accumulation; 10024967

• Registration Number: NL-OMON52221
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• admission to one of the participating ICUs; and
• intubated with an endotracheal tube; and
• expected to need invasive ventilation for more than 48 hours from
consideration for inclusion.

Exclusion Criteria

age <18 years;
already use of MI-E before hospital admission, i.e., at home; known presence of
bullous emphysema; known bronchopleural fistula; known pneumothorax or
pneumomediastinum; known rib fractures or unstable spinal fractures; unsecured
subarachnoidal haemorrhage; uncontrollable intracranial pressures. Patients in
aerogenic isolation, apart from cohort isolation due to COVID-19, are also
excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the proportion of delivered MI-E sessions (2 times a<br /><br>MI-E session of 3 cycles per calendar day) per patient according to study<br /><br>protocol (feasibility). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the total number of serious adverse events (incidence of<br /><br>pneumothorax and serious hemodynamic of pulmonary instability) in relation to<br /><br>MI-E (safety) and preliminary exploratory data on clinical outcomes including<br /><br>duration of invasive ventilation, length of stay in ICU and mortality<br /><br>(efficacy).</p><br>