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

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

Status: Terminated

Conditions: Critically Ill

Treatments: Device: Mechanical Insufflation-Exsufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT06027008

ACACIA

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7 participants in 2 patient groups

Mechanical Insufflation-Exsufflation

Experimental group

Description:

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.

Treatment:

Device: Mechanical Insufflation-Exsufflation

Standard airway care

No Intervention group

Description:

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.