Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

Ventilator Weaning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999526
• Other study ID #: CHUnimed
• Secondary ID: 70984323.1.1001.
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Centro Hospitalar Unimed de Joinville
• Contact: Aline Braz Pereira
• Phone: +55 (47) 99181-8400
• Email: linibp[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Extubation
• Ventilator Weaning

Intervention

Other:
• Reconnection 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.
• Direct extubation
The participant will be extubated immediately after the spontaneous breathing trial.

Locations

Country	Name	City	State
Brazil	Centro Hospitalar Unimed de Joinville	Joinville	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Unimed de Joinville

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Length of hospital stay from randomization to hospital discharge	At hospital discharge, up to 90 days
Secondary	Mortality in the intensive care unit	Mortality from randomization to intensive care unit discharge	At intensive care unit discharge, up to 90 days
Secondary	Hospital mortality	Mortality from randomization to hospital discharge	At hospital discharge, up to 90 days