Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults — ACACIA  

Critically Ill Clinical Trial

Official title: Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial

Status Recruiting

Clinical Trial 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 aims to answer are:

• Is MI-E feasible?

• Is MI-E safe?

Participants in the intervention group will receive:

• MI-E

• Airway secretions will be removed by endotracheal suctioning, as part of routine airway care.

• Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated.

The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).

Clinical Trial 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-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient. ;

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

• NCT number: NCT06027008
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Frederique Paulus, RN, PHD
• Phone: +31-20-5669111
• Email: f.paulus@amsterdamumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Completion date: June 2025