NCT06027008

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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-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.

Conditions

• Critically Ill

Interventions

Type	Name	Description
DEVICE	Mechanical Insufflation-Exsufflation	MI-E will be applied twice a day in invasively ventilated patients. Since the severity of illness can change in the ICU, each day the attending nurse will check for clinical reasons to not apply MI-E with regard to safety. The following clinical criteria are predefined as a reason to refrain from MI-E at that day: * severe ventilator instability (requiring \> 12 cm H2O PEEP and dependency of \> 60% FiO2); * severe hemodynamic instability (a need for large and sustained increase in continuous administration of intravenous vasopressive medication that are adjusted on a frequent basis in each nursing shift); * extra corporal membrane oxygenation (ECMO); and * deeply sedated patient (RASS score ≤ -4).

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-09-07
• Last updated: 2024-12-10

Locations

1 site across 1 country: Netherlands