Clinical trial NCT05999526: Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial
Official title: Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: a Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Extubation
Ventilator Weaning
Keywords: Rest
Ventilator Weaning
Airway Extubation
Lead sponsor: Centro Hospitalar Unimed de Joinville
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions:

1. Reconnection to mechanical ventilation for 1 hour: as soon as the success of the spontaneous breathing trial is confirmed, the participants will be reconnected to mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.

   In the experimental group, in case there are signs of respiratory distress or other clinical problems during the resting phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.
2. Direct extubation: participants will be extubated immediately after spontaneous breathing trial.
Primary purpose: PREVENTION

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:

1. Reconnection to mechanical ventilation for 1 hour followed by extubation;
2. Direct extubation.

Follow-up will be until hospital discharge or death.


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.

Primary outcomes:
measure: Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
timeFrame: At day of extubation
Secondary outcomes:
measure: Extubation failure within 7 days
timeFrame: Up to 7 days after extubation
measure: Ventilator-free days in 28 days
timeFrame: Up to 28 days after randomization
measure: Length of stay in the intensive care unit
timeFrame: At ICU discharge, up to 90 days
measure: Length of hospital stay
timeFrame: At hospital discharge, up to 90 days
measure: Mortality in the intensive care unit
timeFrame: At intensive care unit discharge, up to 90 days
measure: Hospital mortality
timeFrame: At hospital discharge, up to 90 days
Other outcomes:
Locations:
city: Joinville
country: Brazil
facility: Centro Hospitalar Unimed de Joinville
state: Santa Catarina
Study officials:
References: