PREDILACT: Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
Study Details
Study Description
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.
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult ≥ 18 years old
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Intubation and ventilation > 24 hours
Exclusion Criteria:
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Patients under guardianship or curators
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Opposition to participation in the study by the patient or family member
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Patients with tracheotomy
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Pregnant or breast-feeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bichat - Claude-Bernard hospital | Paris | France | 75018 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Alexy Tran Dinh, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A00111-42