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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05801692
Other study ID # CHUB WAVE
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 21, 2022
Est. completion date October 1, 2023

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Spontaneous breathing trial can be performed with a T-Tube or with Pressure support without PEEP (End Expiratory Positive Pressure) . Duration of spontaneous breathing trial range from 30 minutes to 120 minutes. Some clinicians performed an arterial blood gases at the end of the spontaneous breathing trial but this practice is not really defined and clearly explained in recommendations. Patients can benefit of ventilation support after extubation like non invasive pressure support or high flow nasal canulae. The procedure can be very different from a center to another, especially for arterial blood gases at the end of spontaneous breathing trial. Our aim is to observe in a multicenter study the daily practice of weaning of mechanical ventilation especially for arterial blood gases.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date October 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Older than 18 years - first attempt of weaning of mechanical ventilation Exclusion Criteria: - withholding of life sustaining therapies - spontaneous breathing trial unsuccessful

Study Design


Related Conditions & MeSH terms

  • Weaning of Mechanical Ventilation

Intervention

Procedure:
Weaning of mechanical ventilation
Weaning of mechanical ventilation is the time when the patient is ready for separation from ventilatory support until breathing without invasive support

Locations

Country Name City State
France BARROT Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type of spontaneous breathing trial performed Spontaneous breathing trial is performed either with pressure support or with a T-Piece In the 24 hours of spontaneous breathing trial
Secondary Arterial blood gases at the end of spontaneous breathing trial Arterial blood gases are sometime performed at the end of the spontaneous breathing trial during weaning of mechanical ventilation. Spontaneous breathing trial takes from 30 to 120 minutes In the hour of spontaneous breathing trial
Secondary Duration of spontaneous breathing trial Duration in minutes The day of the spontaneous breathing trial
Secondary Ventilatory procedure at the end of spontaneous breathing trial: either immediate extubation or pressure support ventilation with intubation the procedure at the end of spontaneous: the patient is either extubated immediately or benefit of about one hour of invasive pressure support with the settings before spontaneous breathing trial until extubation. Procedure of extubation is differed of about one hour. The day of extubation if extubation performed
Secondary Frequency and type of ventilatory support after extubation Ventilatory is either not performed or if performed, with pressure support or high flow oxygen nasal canulae The day of extubation if extubation performed
Secondary Need for reintubation Reintubation is the need to reintubate the patient because of extubation failure During the seven days following extubation
Secondary Etiology of reintubation The cause of reintubation (pulmonary edema, infectious pulmonary disease...) During the seven days following extubation
Secondary Death If the patient died The first 28 days following extubation
Secondary Ventilator associated pneumoniae Pneumoniae acquired after more than 48 hours of mechanical ventilation From 48 hours after extubation until extubation
Secondary days alive without mechanical ventilation The number of days without invasive mechanical ventilation support during the first 28 days of intensive care hospitalization. during the first 28 days of intensive care hospitalization.
See also
  Status Clinical Trial Phase
Completed NCT02920281 - Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation N/A
Completed NCT02138903 - A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial N/A
Completed NCT01464567 - Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation Phase 4