Clinical trial NCT05487573: Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
Official title: Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Extubation Failure
Keywords: Extubation failure
spontaneous breathing trial (SBT)
lactatemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized in intensive care, on invasive mechanical ventilation for more than 24 hours, and performing a spontaneous ventilation trial will be eligible for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the variation in arterial lactate concentration
timeFrame: 72 hours
Secondary outcomes:
measure: Arterial lactate concentration before the spontaneous ventilation trial
timeFrame: 30 minutes
measure: Arterial lactate concentration after the spontaneous ventilation trial
timeFrame: 30 minutes
measure: Diagnostic performance of the variation in arterial lactate concentration
timeFrame: 72 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat - Claude-Bernard hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexy Tran Dinh, PhD
role: PRINCIPAL_INVESTIGATOR
References: