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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)7 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Mechanical Insufflation-ExsufflationDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

Time frame: max. 7 days

Secondary Outcomes

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)

Time frame: max 7 days

incidence of endotracheal tube obstruction (safety)

incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care

Time frame: max 7 days

incidence of severe hypoxemia (safety)

incidence of severe hypoxemia

Time frame: max 7 days

incidence of severe hypotension (safety)

incidence of severe hypotension

Time frame: max 7 days

incidence of severe hypertension (safety)

incidence of severe hypertension

Time frame: max 7 days

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)

Time frame: through study completion, estimated one year

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)

Time frame: through study completion, estimated one year

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)

Time frame: through study completion, estimated one year

amount of time needed for MI-E (feasibility)

time needed to deliver the MI-E intervention

Time frame: maximum of 1 hour per session

endotracheal suctioning (feasibility)

frequency of endotracheal suctioning per ventilation day

Time frame: max. 7 days

MH (feasibility of MI-E)

frequency of manual hyperinflation

Time frame: max. 7 days

VAP (efficacy MI-E sample size calculation)

incidence of ventilator associated pneumonia (VAP)