Is it possible to complete a large study to see whether using a cough device in ICU can help remove breathing support in ICU patients?

Not Applicable

• Conditions: Resuming self breathing after breathing support in ICU; Respiratory

• Registration Number: ISRCTN24603037
• Lead Sponsor: niversity Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37488566/ (added 25/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-16
• Last Update Posted: 3 October 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 47

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified