Status:
TERMINATED
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Critically Ill
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients. The main question\[s\] it...
Detailed Description
Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively ventilated. MI...
Eligibility Criteria
Inclusion
- admission to one of the participating ICUs;
- receiving invasive mechanical ventilation via an endotracheal tube; and
- expected to need invasive ventilation for more than 48 hours from consideration for inclusion.
Exclusion
- 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;
- known barotrauma;
- known unstable spinal fractures;
- unsecured subarachnoidal haemorrhage;
- uncontrollable intracranial pressures; and
- any infection, or colonization with pathogens that requires strict aerogenic isolation. With an exception for patients in cohort isolation due to COVID-19.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06027008
Start Date
October 30 2023
End Date
October 1 2024
Last Update
December 10 2024
Active Locations (1)
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1
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands