Protocolised trial of invasive and non-invasive weaning off ventilation (The 'Breathe' Study)

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care; Respiratory; Respiratory failure, unspecified

• Registration Number: ISRCTN15635197
• Lead Sponsor: Heart of England NHS Foundation Trust (UK)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30347090 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31532358 (added 19/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-29
• Study Completion: 2017-07-31
• Last Update Posted: 14 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

1. Male and female, age > 16 years
2. Patients with respiratory failure who have received invasive ventilation for more than 48 hours (from the time of intubation)
3. Fail a spontaneous breathing trial (SBT)
4. Provision of written informed consent

The trial inclusion criteria will be adult patients with respiratory failure who have received invasive ventilation for more than 48 hours (from the time of intubation) and fail a SBT. We will not include patients who require shorter periods of invasive ventilation or those who pass the SBT as this group are typically rapidly weaned and have good clinical outcomes.

Exclusion Criteria

1. Presence of tracheostomy
2. Profound neurological deficit
3. Any absolute contraindication to NIV
4. Home ventilation prior to ICU admission
5. Decision not to re-intubate or withdrawal of care anticipated
6. Further surgery / procedure requiring sedation planned in next 48 hours
7. Previous participation in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified