Arterial Blood Gases in Weaning of Mechanical VEntilation (WAVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Weaning of Mechanical Ventilation
• Intervention / Treatment: Procedure: Weaning of mechanical ventilation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25320
    • BARROT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in intensive care unit with invasive mechanical ventilation, first attempt of weaning of mechnical ventilation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of spontaneous breathing trial	Duration in minutes	The day of the spontaneous breathing trial
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
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
Need for reintubation	Reintubation is the need to reintubate the patient because of extubation failure	During the seven days following extubation
Etiology of reintubation	The cause of reintubation (pulmonary edema, infectious pulmonary disease...)	During the seven days following extubation
Death	If the patient died	The first 28 days following extubation
Ventilator associated pneumoniae	Pneumoniae acquired after more than 48 hours of mechanical ventilation	From 48 hours after extubation until extubation
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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHUB WAVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No