Suspended

PREDILACTPerformance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: September 2022
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactAlexy Tran Dinh, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2022

Actual date on which the first participant was enrolled.

Extubation failure (EF) is defined as the need for reintubation within 48-72 hour. This complication is independently associated with a seven-fold increased risk of death in critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator. However, EF occurs in 10 to 20% of patients despite having successful SBT. Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin. The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia, regardless of the cause of failure. The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.

Official TitlePerformance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
NCT05487573
Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactAlexy Tran Dinh, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

242 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Adult ≥ 18 years old

Intubation and ventilation > 24 hours

4 exclusion criteria prevent from participating
Patients under guardianship or curators

Opposition to participation in the study by the patient or family member

Patients with tracheotomy

Pregnant or breast-feeding women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bichat - Claude-Bernard hospital

Paris, FranceOpen Bichat - Claude-Bernard hospital in Google Maps
SuspendedOne Study Center
PREDILACT | Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure | PatLynk