Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
- Conditions
- Critically Ill
- Interventions
- Device: Mechanical Insufflation-Exsufflation
- Registration Number
- NCT06027008
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mechanical Insufflation-Exsufflation Mechanical Insufflation-Exsufflation 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.
- Primary Outcome Measures
Name Time Method intervention delivery max. 7 days 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
- Secondary Outcome Measures
Name Time Method incidence of severe hypertension (safety) max 7 days incidence of severe hypertension
VAP (efficacy MI-E sample size calculation) 28 days after inclusion incidence of ventilator associated pneumonia (VAP)
duration MV (efficacy MI-E sample size calculation) 28 days after inclusion duration of invasive ventilation
incidence of severe hypoxemia (safety) max 7 days incidence of severe hypoxemia
VFD-28 (efficacy MI-E sample size calculation) 28 days after inclusion ventilator-free days at day 28
hospital mortality (efficacy MI-E sample size calculation) 28 days after inclusion hospital mortality
LOS ICU (efficacy MI-E sample size calculation) 28 days after inclusion length of stay in ICU
amount of time needed for MI-E (feasibility) maximum of 1 hour per session time needed to deliver the MI-E intervention
incidence of pneumothorax (safety) max 7 days incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)
incidence of endotracheal tube obstruction (safety) max 7 days incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care
incidence of severe hypotension (safety) max 7 days incidence of severe hypotension
Feasibility of Intervention Measure (FIM) through study completion, estimated one year 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
LOS hospital (efficacy MI-E sample size calculation) 28 days after inclusion length of stay in hospital
Acceptability of Intervention Measure (AIM) through study completion, estimated one year 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Intervention Appropriateness Measure (IAM) through study completion, estimated one year 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
endotracheal suctioning (feasibility) max. 7 days frequency of endotracheal suctioning per ventilation day
MH (feasibility of MI-E) max. 7 days frequency of manual hyperinflation
ICU mortality (efficacy MI-E sample size calculation) 28 days after inclusion ICU mortality
supplemental oxygen (efficacy MI-E sample size calculation) 28 days after inclusion use of supplemental oxygen on ICU delivery after detubation
Mortality day 28 (efficacy MI-E sample size calculation) up to day 28 from ICU admission mortality at day 28
Trial Locations
- Locations (1)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
🇳🇱Amsterdam, Netherlands