Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

NCT05999526 | Completed

• 2 other identifiers: CHUnimed70984323.1.1001.5362
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Extubation; Ventilator Weaning

Keywords

Rest; Ventilator Weaning; Airway Extubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Extubation failure within 7 days

  Up to 7 days after extubation

• Ventilator-free days in 28 days

  Up to 28 days after randomization

• Length of stay in the intensive care unit

  At ICU discharge, up to 90 days

• Length of hospital stay

  At hospital discharge, up to 90 days

• Mortality in the intensive care unit

  At intensive care unit discharge, up to 90 days

Study Arms (2)

Reconnection to mechanical ventilation for 1 hour

EXPERIMENTAL

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

Direct extubation

ACTIVE COMPARATOR

The participant will be extubated immediately after the spontaneous breathing trial.

Other: Direct extubation

Interventions

Reconnection to mechanical ventilation for 1 hour OTHER

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.

Reconnection to mechanical ventilation for 1 hour

Direct extubation OTHER

The participant will be extubated immediately after the spontaneous breathing trial.

Direct extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar Unimed de Joinville: lead

Study Sites (1)

Centro Hospitalar Unimed de Joinville

Joinville, Santa Catarina, 89204-061, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: November 2, 2023
• Primary Completion: March 22, 2024
• Study Completion: June 15, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)