Clinical trial NCT06027008: Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
Official title: Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critically Ill
Keywords: Mechanical insufflation-exsufflation
Cough Assist
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized feasibility trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: intervention delivery
timeFrame: max. 7 days
Secondary outcomes:
measure: incidence of pneumothorax (safety)
timeFrame: max 7 days
measure: incidence of endotracheal tube obstruction (safety)
timeFrame: max 7 days
measure: incidence of severe hypoxemia (safety)
timeFrame: max 7 days
measure: incidence of severe hypotension (safety)
timeFrame: max 7 days
measure: incidence of severe hypertension (safety)
timeFrame: max 7 days
measure: Acceptability of Intervention Measure (AIM)
timeFrame: through study completion, estimated one year
measure: Intervention Appropriateness Measure (IAM)
timeFrame: through study completion, estimated one year
measure: Feasibility of Intervention Measure (FIM)
timeFrame: through study completion, estimated one year
measure: amount of time needed for MI-E (feasibility)
timeFrame: maximum of 1 hour per session
measure: endotracheal suctioning (feasibility)
timeFrame: max. 7 days
measure: MH (feasibility of MI-E)
timeFrame: max. 7 days
measure: VAP (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: duration MV (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: Mortality day 28 (efficacy MI-E sample size calculation)
timeFrame: up to day 28 from ICU admission
measure: VFD-28 (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: ICU mortality (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: hospital mortality (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: supplemental oxygen (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: LOS ICU (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
measure: LOS hospital (efficacy MI-E sample size calculation)
timeFrame: 28 days after inclusion
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study officials:
affiliation: Amsterdam UMC - intensive care
name: Frederique Paulus, RN, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2023 Nov;28(6):923-930. doi: 10.1111/nicc.12858. Epub 2022 Dec 4.
citation: Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.
citation: Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.