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

Not yet recruiting

• Conditions: Extubation Failure

• Registration Number: NCT05487573
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Extubation failure (EF) is independently associated with excess mortality of 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.

Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia.

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15
• Study Start: 2022-09-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Adult ≥ 18 years old
• Intubation and ventilation > 24 hours

Exclusion Criteria

• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the variation in arterial lactate concentration	72 hours	Evaluation of the variation in arterial lactate concentration measured before and after spontaneous ventilation trial in during weaning from invasive mechanical ventilation to predict extubation failure.

Secondary Outcome Measures

Name	Time	Method
Arterial lactate concentration before the spontaneous ventilation trial	30 minutes	Measurement of arterial lactate concentration (mmol/L) before the spontaneous ventilation trial.
Arterial lactate concentration after the spontaneous ventilation trial	30 minutes	Measurement of arterial lactate concentration (mmol/L) after the spontaneous ventilation trial and before reconnection to mechanical ventilation.
Diagnostic performance of the variation in arterial lactate concentration	72 hours	Calculation of the area under the receiver operating characteristic curves (AUROC) for the variation in arterial lactate concentration measured before and after spontaneous ventilation trial.

Trial Locations

Locations (1)

Bichat - Claude-Bernard hospital; 🇫🇷 Paris, France