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

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Extubation Failure

Study type

Observational

Funder types

Other

Identifiers

NCT05487573
2022-A00111-42

Details and patient eligibility

About

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.

Full 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.

Enrollment

242 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Alexy Tran Dinh, PhD

Data sourced from clinicaltrials.gov

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