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

Critically Ill Clinical Trial

— ACACIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027008
• Other study ID #: ACACIA
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Frederique Paulus, RN, PHD
• Phone: +31-20-5669111
• Email: f.paulus[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intervention delivery	the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation	max. 7 days
Secondary	incidence of pneumothorax (safety)	incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)	max 7 days
Secondary	incidence of endotracheal tube obstruction (safety)	incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care	max 7 days
Secondary	incidence of severe hypoxemia (safety)	incidence of severe hypoxemia	max 7 days
Secondary	incidence of severe hypotension (safety)	incidence of severe hypotension	max 7 days
Secondary	incidence of severe hypertension (safety)	incidence of severe hypertension	max 7 days
Secondary	Acceptability of Intervention Measure (AIM)	1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)	through study completion, estimated one year
Secondary	Intervention Appropriateness Measure (IAM)	1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)	through study completion, estimated one year
Secondary	Feasibility of Intervention Measure (FIM)	1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)	through study completion, estimated one year
Secondary	amount of time needed for MI-E (feasibility)	time needed to deliver the MI-E intervention	maximum of 1 hour per session
Secondary	endotracheal suctioning (feasibility)	frequency of endotracheal suctioning per ventilation day	max. 7 days
Secondary	MH (feasibility of MI-E)	frequency of manual hyperinflation	max. 7 days
Secondary	VAP (efficacy MI-E sample size calculation)	incidence of ventilator associated pneumonia (VAP)	28 days after inclusion
Secondary	duration MV (efficacy MI-E sample size calculation)	duration of invasive ventilation	28 days after inclusion
Secondary	Mortality day 28 (efficacy MI-E sample size calculation)	mortality at day 28	up to day 28 from ICU admission
Secondary	VFD-28 (efficacy MI-E sample size calculation)	ventilator-free days at day 28	28 days after inclusion
Secondary	ICU mortality (efficacy MI-E sample size calculation)	ICU mortality	28 days after inclusion
Secondary	hospital mortality (efficacy MI-E sample size calculation)	hospital mortality	28 days after inclusion
Secondary	supplemental oxygen (efficacy MI-E sample size calculation)	use of supplemental oxygen on ICU delivery after detubation	28 days after inclusion
Secondary	LOS ICU (efficacy MI-E sample size calculation)	length of stay in ICU	28 days after inclusion
Secondary	LOS hospital (efficacy MI-E sample size calculation)	length of stay in hospital	28 days after inclusion