Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

Study Overview
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Brief Summary
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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.

Official Title
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Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: A Randomized Controlled Feasibility Trial

Conditions
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Airway Extubation, Ventilator Weaning

Intervention / Treatment
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* Other: Reconnection to mechanical ventilation for 1 hour
* Other: Direct extubation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions: 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. Direct extubation: participants will be extubated immediately after spontaneous breathing trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reconnection to mechanical ventilation for 1 hour<br>As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. | Other: Reconnection to mechanical ventilation for 1 hour<br>* As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.<br>|
| Active Comparator: Direct extubation<br>The participant will be extubated immediately after the spontaneous breathing trial. | Other: Direct extubation<br>* The participant will be extubated immediately after the spontaneous breathing trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups | 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). | At day of extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure within 7 days | Defined as a composite criterion of reintubation or death 7 days after extubation; Weaning failure will be defined as failure within 7 days after extubation requiring reintubation and invasive mechanical ventilation, whether post-extubation noninvasive ventilation was used or not. The choice of the composite outcome was made to consider possible participants who die before 7 days without being reintubated. The choice of time for the 7-day outcome was based on the fact that the time interval to define extubation success varies in the literature, and on the evidence that many participants are reintubated after 48-72 hours, making these times early to assess reintubation, especially in cases of prophylactic use of noninvasive ventilation or post-extubation high flow nasal cannula. | Up to 7 days after extubation | 
| Ventilator-free days in 28 days | Defined as the number of days from the time of extubation and initiation of unassisted breathing to day 28 after randomization. If a participant dies before day 28, days without ventilation will be counted as zero. If a participant is reintubated and returned to mechanical ventilation and is later extubated again and remains on unassisted breathing through day 28, ventilation-free days will be counted from the end of the last assisted breathing period through day 28. One period of invasive mechanical ventilation lasting less than 24 hours and for the purposes of the surgical procedure will count as 1 day free of mechanical ventilation. Participants who are discharged from the hospital on unassisted breathing before 28 days will be considered ventilator-free for the remaining days up to 28 days. | Up to 28 days after randomization | 
| Length of stay in the intensive care unit | Length of hospital stay from randomization to intensive care unit discharge | At ICU discharge, up to 90 days | 
| Length of hospital stay | Length of hospital stay from randomization to hospital discharge | At hospital discharge, up to 90 days | 
| Mortality in the intensive care unit | Mortality from randomization to intensive care unit discharge | At intensive care unit discharge, up to 90 days | 
| Hospital mortality | Mortality from randomization to hospital discharge | At hospital discharge, up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rest, Ventilator Weaning, Airway Extubation