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

Extubation Failure Clinical Trial

— PREDILACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05487573
• Other study ID #: 2022-A00111-42
• Status: Not yet recruiting
• Start date: September 15, 2022
• Est. completion date: October 15, 2025

Study information

• Verified date: July 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alexy Tran Dinh, PhD
• Phone: 1 40 25 83 54
• Email: alexy.trandinh[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extubation Failure
• Respiratory Aspiration

Locations

Country	Name	City	State
France	Bichat - Claude-Bernard hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the variation in arterial lactate concentration	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.	72 hours
Secondary	Arterial lactate concentration before the spontaneous ventilation trial	Measurement of arterial lactate concentration (mmol/L) before the spontaneous ventilation trial.	30 minutes
Secondary	Arterial lactate concentration after the spontaneous ventilation trial	Measurement of arterial lactate concentration (mmol/L) after the spontaneous ventilation trial and before reconnection to mechanical ventilation.	30 minutes
Secondary	Diagnostic performance of the variation in arterial lactate concentration	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.	72 hours