Resuming self breathing after breathing support in ICU Respiratory
Conditions
Interventions
This study is a single centre, parallel group, randomised controlled trial with economic scoping, nested exploratory physiology study and nested qualitative study. The study protocol has been develope
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (>=16 years) 2. Expected to require invasive mechanical ventilation for >48hrs 3. Clinician identified pre-extubation problems with secretion management defined as poor/weak cough effort (cough peak flow <60L/min) and/or secretion load that are difficult to clear with usual airway clearance management (as assessed by the treating clinical team) 4. Identified as ‘ready to wean or weaning’ by the treating clinical team (on a spontaneous mode of ventilation for example Continuous Positive Airway Pressure (CPAP); Assisted Spontaneous Breathing (ASB); Pressure Support Ventilation (PSV); Airway Pressure Release Ventilation (APRV) (with spontaneous effort).
Exclusion criteria
Exclusion criteria: 1. Positive End Expiratory Pressure (PEEP) >10 2. Fraction of Inspired Oxygen (FiO2) >0.7 3. Hemodynamic/Cardiovascular instability (i.e. noradrenaline >0.25mg/kg, arrhythmias requiring intervention) 4. Recent undrained pneumothorax (current admission with no chest drain in situ); 5. Unable to continue to use MI-E post extubation (i.e. contraindications to facemask use-facial/cranial trauma, recent facial surgery; active upper gastrointestinal bleeding/uncontrolled vomiting; recent upper abdominal/thoracic surgery with at risk anastomosis) 6. Pre-existing neuromuscular respiratory condition 7. Pre-existing routine use of MI-E in the community 8. Patients with pre-existing permanent tracheostomy 9. Treatment withdrawal expected within 24hrs or not expected to survive 10. Re-admission to ICU following index admission 11. Previous MERIT trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes measured at the end of the study: 1. Proportion of eligible patients approached, consented and randomised measured using screening log and randomization records 2. Proportion of MI-E treatment sessions completed measured using case report form 3. Proportion of recruited patients with all outcome measures recorded measured using case report form 4. Attrition (participant withdrawal and loss to follow up) measured using case report form and withdrawal records 5. Acceptability of trial processes to participants and clinicians measured using qualitative interviews, acceptability of intervention measure (AIM)/Intervention appropriate measure (IAM)/feasibility of intervention measure (FIM) 6. Acceptability of outcome measures to participants and clinicians measured using qualitative interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Resource use (use of HFNC, NIV, trachy; MI-E equipment, staff grade and time) at end of each treatment intervention and per 24hr period 2. Lung ultrasound score pre intervention and 5mins post intervention 3. Pain is measured using the numeric rating scale and/or critical care pain observation tool (CPOT) 4. QOL is measured using the EQ-5D-5L at 6 months following ICU discharge 5. Re-intubation rate will be calculated at 48hours post extubation 6. Mortality will be calculated at 60days post randomisation 7. Cardiovascular parameters (heart rate, systolic and diastolic blood pressure) measured at pre intervention, intervention end and 5mins post intervention 8. Ventilator/respiratory parameters (lung resistance/compliance, respiratory rate, peripheral oxygen saturations) measured pre intervention, intervention end and post extubation) 9. Adverse events (occurrence frequency of HR, SBP, DBP increase/decrease >20% baseline; arrhythmia requiring intervention; pneumothorax; acute desaturation to 10% below baseline; cardiopulmonary arrest; accidental extubation) measured at end of intervention and 5 mins post intervention end | — |
Countries
England, United Kingdom
Outcome results
None listed