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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05487573
Acronym
PREDILACT
Enrollment
242
Registered
2022-08-04
Start date
2022-09-15
Completion date
2025-10-15
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Failure

Keywords

Extubation failure, spontaneous breathing trial (SBT), lactatemia

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the variation in arterial lactate concentration72 hoursEvaluation 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

MeasureTime frameDescription
Arterial lactate concentration before the spontaneous ventilation trial30 minutesMeasurement of arterial lactate concentration (mmol/L) before the spontaneous ventilation trial.
Arterial lactate concentration after the spontaneous ventilation trial30 minutesMeasurement 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 concentration72 hoursCalculation of the area under the receiver operating characteristic curves (AUROC) for the variation in arterial lactate concentration measured before and after spontaneous ventilation trial.

Countries

France

Contacts

Primary ContactAlexy Tran Dinh, PhD
alexy.trandinh@aphp.fr1 40 25 83 54

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026