Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2024-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure

NCT07019636

Weaning From Mechanical Ventilation, Extubation

NOT_YET_RECRUITING NA

Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

NCT00557999

Mechanical Ventilation Cardiomyopathy

COMPLETED NA

ONE-HOUR POSITIVE PRESSURE VENTILATION AFTER A PRESSURE SUPPORT SPONTANEOUS BREATHING TRIAL: A RANDOMIZED CLINICAL TRIAL

NCT07324460

Airway Extubation Weaning Mechanical Ventilation Extubation Failure

NOT_YET_RECRUITING NA

Speeding the Weaning up: Aggressive Screening Criteria and Higher Minimal Ventilatory Settings.

NCT04758546

Weaning Failure

COMPLETED NA

Ventilation Strategies During Spontaneous Breathing Trial

NCT02939963

Acute Respiratory Insufficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Extubation Ventilator Weaning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Reconnection to mechanical ventilation for 1 hour

Intervention Type 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.

Direct extubation

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

Group Type ACTIVE_COMPARATOR

Direct extubation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Direct extubation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No