Perkins 2013.
| Trial name or title | Protocolized trial of invasive and noninvasive weaning off ventilation: the BREATHE trial |
| Methods | RCT (n = 920) http://www.warwick.ac.uk/breathe Allocation concealment not described |
| Participants | Participants with respiratory failure who received invasive ventilation for longer than 48 hours (from the time of intubation) and who failed a spontaneous breathing test (SBT) Inclusion criteria: 1. Male and female participants, age > 16 years 2. Participants with respiratory failure who had received invasive ventilation for longer than 48 hours (from intubation) 3. Failure of an SBT 4. Provision of written informed consent Exclusion criteria: 1. Presence of a tracheostomy 2. Profound neurological deficits 3. Any absolute contraindication to NIV 4. Home ventilation before ICU admission 5. Decision not to reintubate or withdrawal of care 6. Further surgery/procedure requiring sedation planned in the next 48 hours 7. Previous participation in the trial |
| Interventions | Invasive versus noninvasive weaning Protocolized invasive weaning arm: The participant will be restarted on PS ventilation at the previous settings. The level of PS will be titrated to achieve comfort and RR < 30 breaths/min. Causes for distress/fatigue/weaning failure will be sought and corrective treatments initiated as appropriate. The participant will be reassessed every two hours. If no signs of distress are noted, the level of PS will be reduced by 2 cm H2O. If at any stage the participant develops distress/fatigue, the PS will be increased by 2 cm H2O. FiO2 will be titrated to maintain SaO2 > 90%. A further SBT will take place each morning. This cycle will continue until the participant has been extubated (passing an SBT or tolerating PS 5 cm H2O) or a tracheostomy has been performed Protocolized noninvasive weaning arm: Participants will be extubated and immediately provided with NIV with an equivalent level of PS and PEEP to the ventilator settings before extubation. After two hours, if no signs of distress/fatigue are observed, the NIV interface will be removed and the participant will undergo a self‐ventilation trial with supplemental oxygen (equivalent to the previous FiO2) via a standard oxygen mask. If no signs of distress or fatigue develop during the self ventilation trial, the participant will continue to receive unsupported ventilation, with inhaled oxygen provided as required. If the participant subsequently develops signs of distress or fatigue, NIV will be restarted (as below). Otherwise, the participant will continue with unsupported self ventilation. FiO2 will be titrated to maintain SaO2 > 90%. If signs of distress or fatigue develop, NIV will be reinstated at the previous settings. The level of PS will be titrated to achieve participant comfort and a RR < 30 breaths/min. Causes for distress/fatigue/weaning failure will be sought and corrective treatments initiated as appropriate. The participant will be reassessed every two hours. If no signs of distress/fatigue are noted, a further trial of self ventilation will be commenced as described above. NIV will be withdrawn when the participant tolerates 12 hours of unsupported spontaneous ventilation In both groups, the active weaning protocol will occur between 8 am and 10 pm. Unless participants develop signs of fatigue or distress, ventilator settings will not be adjusted overnight |
| Outcomes | Primary: time from randomization to liberation from ventilation Secondary Efficacy: 1. Mortality at 30, 90 and 180 days 2. Duration of invasive mechanical ventilation and total ventilator‐free days (invasive and noninvasive ventilation) 3. Time to meeting ICU discharge criteria (defined as no further requirement for level 2/3 care) 4. Proportion of participants receiving antibiotics for presumed respiratory infection and total antibiotic days 5. Reintubation rates (protocolized end point and actual events) 6. Tracheostomy Safety 1. Adverse events 2. Serious adverse events Patient‐focused outcomes Health‐related quality of life, EuroQol, EQ‐5D and SF12 at baseline (estimated) and at three and six months |
| Starting date | 1 January 2013 |
| Contact information | Mrs Beverley Hoddell, Clinical Trials Unit, Warwick Medical School, Gibbet Hill Road, Coventry, UK b.hoddell@warwick.ac.uk |
| Notes |