Airway Extubation, Ventilator Weaning
Conditions
Keywords
Rest, Ventilator Weaning, Airway Extubation
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.
Interventions
OTHERReconnection to mechanical ventilation for 1 hour
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.
OTHERDirect extubation
The participant will be extubated immediately after the spontaneous breathing trial.
Sponsors
Centro Hospitalar Unimed de Joinville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days in 28 days | Up to 28 days after randomization | 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. |
| Length of stay in the intensive care unit | At ICU discharge, up to 90 days | Length of hospital stay from randomization to intensive care unit discharge |
| Extubation failure within 7 days | Up to 7 days after extubation | 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. |
| Mortality in the intensive care unit | At intensive care unit discharge, up to 90 days | Mortality from randomization to intensive care unit discharge |
| Hospital mortality | At hospital discharge, up to 90 days | Mortality from randomization to hospital discharge |
| Length of hospital stay | At hospital discharge, up to 90 days | Length of hospital stay from randomization to hospital discharge |
Countries
Brazil
Outcome results
None listed