Critically Ill
Conditions
Keywords
Mechanical insufflation-exsufflation, Cough Assist
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.
Interventions
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).
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Randomized feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of severe hypotension (safety) | max 7 days | incidence of severe hypotension |
| incidence of severe hypertension (safety) | max 7 days | incidence of severe hypertension |
| 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 |
| 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) |
| 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) |
| amount of time needed for MI-E (feasibility) | maximum of 1 hour per session | time needed to deliver the MI-E intervention |
| endotracheal suctioning (feasibility) | max. 7 days | frequency of endotracheal suctioning per ventilation day |
| incidence of severe hypoxemia (safety) | max 7 days | incidence of severe hypoxemia |
| 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 |
| Mortality day 28 (efficacy MI-E sample size calculation) | up to day 28 from ICU admission | mortality at day 28 |
| VFD-28 (efficacy MI-E sample size calculation) | 28 days after inclusion | ventilator-free days at day 28 |
| ICU mortality (efficacy MI-E sample size calculation) | 28 days after inclusion | ICU mortality |
| hospital mortality (efficacy MI-E sample size calculation) | 28 days after inclusion | hospital mortality |
| supplemental oxygen (efficacy MI-E sample size calculation) | 28 days after inclusion | use of supplemental oxygen on ICU delivery after detubation |
| LOS ICU (efficacy MI-E sample size calculation) | 28 days after inclusion | length of stay in ICU |
| LOS hospital (efficacy MI-E sample size calculation) | 28 days after inclusion | length of stay in hospital |
| MH (feasibility of MI-E) | max. 7 days | frequency of manual hyperinflation |
Countries
Netherlands
Outcome results
None listed