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

NCT05487573 | Unknown

• 1 other identifier: 2022-A00111-42
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation Failure

Keywords

Extubation failure; spontaneous breathing trial (SBT); lactatemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Arterial lactate concentration before the spontaneous ventilation trial

  30 minutes

• Arterial lactate concentration after the spontaneous ventilation trial

  30 minutes

• Diagnostic performance of the variation in arterial lactate concentration

  72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult ≥ 18 years old
• Intubation and ventilation \> 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat - Claude-Bernard hospital

Paris, 75018, France

Location

Study Officials

• Alexy Tran Dinh, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexy Tran Dinh, PhD

CONTACT

1 40 25 83 54; alexy.trandinh@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: September 15, 2022
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: August 15, 2022

Record last verified: 2022-07

Locations

FR (1)