Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: a Randomized Controlled Feasibility Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Airway Extubation
- Sponsor
- Centro Hospitalar Unimed de Joinville
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of this study is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical ventilation. The study will compare two weaning strategies in critically ill participants admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:
- Reconnection to mechanical ventilation for 1 hour followed by extubation;
- Direct extubation.
Follow-up will be until hospital discharge or death.
Investigators
Aline Braz Pereira
Principal Investigator
Centro Hospitalar Unimed de Joinville
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years;
- •Admission to the intensive care unit;
- •Orotracheal intubation;
- •Mechanical ventilation for more than 72 hours;
- •Spontaneous breathing trial (according to the study protocol) successful and considered able to be extubated.
Exclusion Criteria
- •Patients unable to obey commands;
- •Unplanned extubation;
- •Neuromuscular disease and cervical spinal cord injury;
- •Tracheostomy;
- •Contraindication for cardiopulmonary resuscitation or reintubation;
- •Absence of informed consent.
Outcomes
Primary Outcomes
Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
Time Frame: At day of extubation
Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour \[+/-10 min\] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).
Secondary Outcomes
- Ventilator-free days in 28 days(Up to 28 days after randomization)
- Hospital mortality(At hospital discharge, up to 90 days)
- Extubation failure within 7 days(Up to 7 days after extubation)
- Length of hospital stay(At hospital discharge, up to 90 days)
- Mortality in the intensive care unit(At intensive care unit discharge, up to 90 days)
- Length of stay in the intensive care unit(At ICU discharge, up to 90 days)