Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

Centro Hospitalar Unimed de Joinville

Status: Completed

Conditions: Ventilator Weaning; Airway Extubation

Treatments: Other: Reconnection to mechanical ventilation for 1 hour; Other: Direct extubation

Study type: Interventional

Funder types: Other

Identifiers

NCT05999526

70984323.1.1001.5362 (Registry Identifier)

CHUnimed

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Reconnection to mechanical ventilation for 1 hour

Experimental group

Description:

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.

Treatment:

Other: Reconnection to mechanical ventilation for 1 hour

Direct extubation

Active Comparator group

Description:

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

Treatment:

Other: Direct extubation