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

NCT06027008 | Terminated DMC

• 1 other identifier: ACACIA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Critically Ill

Keywords

Mechanical insufflation-exsufflation; Cough Assist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• incidence of pneumothorax (safety)

  max 7 days

• incidence of endotracheal tube obstruction (safety)

  max 7 days

• incidence of severe hypoxemia (safety)

  max 7 days

• incidence of severe hypotension (safety)

  max 7 days

• incidence of severe hypertension (safety)

  max 7 days

Study Arms (2)

Mechanical Insufflation-Exsufflation

EXPERIMENTAL

Invasively ventilated patients will receive MI-E until successful extubation or for a maximum of 7 days. MI-E will be given in the morning and afternoon each calendar day. Patients will be pre-oxygenated with FiO2 100% prior to disconnection from the ventilator; additional 15 litres oxygen can be added; A pre-set program is used: three times three cycles with 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.

Device: Mechanical Insufflation-Exsufflation

Standard airway care

NO INTERVENTION

Patients in the control group will receive usual airway care which includes endotracheal suctioning and manual hyperinflation used when indicated based on clinical signs as part of regular airway care. Care protocols for endotracheal suctioning and manual hyperinflation are predefined. As with the intervention arm, there will be no use of saline instillation during suctioning. Manual hyperinflation technique is described in the care protocol of the intensive care unit and ICU nurses are trained to perform this technique.

Interventions

Mechanical Insufflation-Exsufflation DEVICE

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).

Also known as: Cough assist

Mechanical Insufflation-Exsufflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admission to one of the participating ICUs;
• receiving invasive mechanical ventilation via an endotracheal tube; and

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 36464804 BACKGROUND

• 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.

  PMID: 35610033 BACKGROUND

• 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.

  PMID: 28075489 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederique Paulus, RN, PHD

  Amsterdam UMC - intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of healthcare professionals and any research personnel involved in the delivery of the intervention is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Randomized feasibility trial

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: September 7, 2023
• Study Start: October 30, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)