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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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.
The participant will be extubated immediately after the spontaneous breathing trial.
Centro Hospitalar Unimed de Joinville
Joinville, Santa Catarina, Brazil
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).
Time frame: At day of extubation
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.
Time frame: 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.
Time frame: 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
Time frame: At ICU discharge, up to 90 days
Length of hospital stay
Length of hospital stay from randomization to hospital discharge
Time frame: At hospital discharge, up to 90 days
Mortality in the intensive care unit
Mortality from randomization to intensive care unit discharge
Time frame: At intensive care unit discharge, up to 90 days
Hospital mortality
Mortality from randomization to hospital discharge
Time frame: At hospital discharge, up to 90 days
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