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

Conditions

Topic: Generic Health Relevance and Cross Cutting Themes

Gavin D. Perkins, Dipesh Mistry, Ranjit Lall, Fang Gao Smith, Catherine Snelson et al. (27 authors)

Health Technology Assessment2019-09-0117 citations

Effect of Protocolized Weaning With Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure

Gavin D. Perkins, Dipesh Mistry, Simon Gates, Fang Gao, Catherine Snelson et al. (20 authors)

JAMA2018-10-22100 citations

10.1001/jama.2018.13763

Interventions

The health technology being assessed is the use of NIV as an adjunct to protocolised weaning compared to protocolised weaning that does not include NIV following a failed spontaneous breathing trial.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Time from randomisation to liberation from ventilation	—

Secondary

Measure	Time frame
Efficacy: 1. Mortality at 30, 90 and 180 days 2. Duration of IMV and total ventilator days (invasive and non-invasive ventilation) 3. Time to meeting ICU discharge criteria (defined as no further requirement for level 2/3 care) 4. Proportion of patients receiving antibiotics for presumed respiratory infection and total antibiotic days 5. Re-intubation rates (protocolised end-point and actual event) 6. Tracheostomy Safety: 1. Adverse events 2. Serious adverse events Patient focused outcomes: Health-related quality of life, measured using EuroQol, EQ-5D, SF12 at baseline (estimated), 3 and 6 months	—

Measure

Time frame

Efficacy: 1. Mortality at 30, 90 and 180 days 2. Duration of IMV and total ventilator days (invasive and non-invasive ventilation) 3. Time to meeting ICU discharge criteria (defined as no further requirement for level 2/3 care) 4. Proportion of patients receiving antibiotics for presumed respiratory infection and total antibiotic days 5. Re-intubation rates (protocolised end-point and actual event) 6. Tracheostomy Safety: 1. Adverse events 2. Serious adverse events Patient focused outcomes: Health-related quality of life, measured using EuroQol, EQ-5D, SF12 at baseline (estimated), 3 and 6 months

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Countries

United Kingdom

Outcome results

None listed