Acute respiratory failure Respiratory Acute respiratory failure
Conditions
Interventions
Current interventions as of 13/11/2023:
Participants will be randomised using an automated web-based or telephone system via randomly permuted blocks in a 1:1:1:1 ratio. There will be stratification
use of isotonic saline may also be used depending on clinician preference.
_____
Previous interventions:
Participants will be randomised using an automated web-based or telephone system via random
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged =16 years 2. An acute and potentially reversible cause of ARF as determined by the treating physician 3. Receiving invasive mechanical ventilation via endotracheal tube or tracheostomy 4. Anticipated to remain on invasive mechanical ventilation for at least 48 hours 5. Presence of secretions that are difficult to clear with usual airway clearance management (as assessed by the treating clinical team)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 13/11/2023: 1. Pre-existing chronic respiratory condition receiving routine use of any mucoactive 2. Mucoactive treatment started more than 24 hours prior to trial enrolment 3. Known adverse reaction to either study mucoactive 4. Treatment withdrawal expected within 24 hours 5. Known pregnancy 6. Previous enrolment in the MARCH trial 7. Declined consent 8. The treating physician believes that participation in the trial would not be in the best interests of the patient _____ Previous exclusion criteria: 1. Pre-existing chronic respiratory condition receiving routine use of any mucoactive 2. Mucoactive treatment started more than 24 hours prior to trial enrolment 3. Known adverse reaction to either study mucoactive 4. Treatment withdrawal expected within 24 hours 5. Known pregnancy 6. Previous enrolment in the MARCH trial 7. Declined consent 8. Prisoners 9. The treating physician believes that participation in the trial would not be in the best interests of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation (in hours), defined (measured) as time from randomisation until first successful unassisted breathing (defined as maintaining unassisted breathing at 48 hours) or death (data obtained from medical notes). This outcome is one of the ‘COVenT’ core outcomes for trials of interventions intended to modify the duration of mechanical ventilation. To clarify: 1. Unassisted breathing is defined as no inspiratory support or extracorporeal lung support 2. Success is defined as maintaining unassisted breathing at 48 hours 3. Duration includes time receiving extracorporeal lung support, invasive mechanical ventilation and non-invasive ventilation delivering volume or pressure support ventilation 4. Duration excludes time receiving high-flow oxygen therapy and continuous positive airway pressure 5. Patients with a tracheostomy in situ may still achieve successful unassisted breathing 6. Follow-up is to 60 days from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint: In hospital 1. Extubation - Time (in hours) from randomisation to first successful extubation (success defined as remaining free from endotracheal or tracheostomy tubes at 48 hours); Censored at 60 days; Data obtained from medical notes 2. Re-intubation - Event of reintubation of endotracheal tube after a planned extubation (censored at hospital discharge); excludes temporary reinsertion of endotracheal tube for procedures only; Censored at 60 days; Data obtained from medical notes 3. Respiratory physiotherapy input - Occurrence and frequency of airway clearance sessions; Censored at ICU discharge, death, or Day 28 whichever occurs first (where extubation occurs on Day 27 or Day 28, respiratory physiotherapy input will be recorded up to Day 29 and Day 30 respectively); Data obtained from medical notes 4. Antibiotic usage – Overall dose of individual agents; Censored at ICU discharge, death, or Day 28 whichever occurs first (where extubation occurs on Day 27 or Day 28, antibiotic usage will be recorded up to Day 29 and Day 30 respectively); Data obtained from medical notes 5. Duration of ICU and hospital stay - Time (in days and hours) from randomisation until the patient first leaves the relevant facility or dies; Censored at 6 months; Data obtained from medical notes 6. All-cause mortality - Confirmation and cause of death; Data obtained from medical notes 7. Safety - Censored at ICU discharge, death, or Day 28 whichever occurs first (where extubation occurs on Day 27 or Day 28, safety outcomes will be recorded up to Day 29 and Day 30 respectively); Data obtained from medical notes; to include the following outcomes: 7.1. Clinically important upper gastrointestinal (GI) bleeding due to peptic ulceration confirmed on upper GI endoscopy 7.2. Bronchoconstriction requiring nebulised bronchodilators 7.3. Ventilator or circuit dysfunction with respiratory deterioration 7.4. Hypoxaemia during nebulisation 7.5. Hospital resource use - Number of days at Level of | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactNaomi Dickson
Outcome results
None listed