Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring for the Prediction of Extubation Failure in the ICU

NCT02894177 | Completed

• 1 other identifier: P15/07_ tcPCO2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Difficult weaning from ventilation and extubation failure are major issues in intensive care, concerning 30% and 12% of patients respectively. These can be partly explained by the lack of accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure. The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2 regarding extubation failure. Therefore, the main objective of this study is to determine if Δ tcPCO2 during SBTs is associated with extubation failure.

Conditions

Ventilator Weaning

Keywords

E02.880.820.950

Outcome Measures

Primary Outcomes (1)

• Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.

  Extubation failure: need for reintubation, rescue non invasive ventilation or death within 7 days following extubation

  7 days

Secondary Outcomes (6)

• Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)

  7 days

• Association between extubation decisions and ΔtcPCO2.

  1 week

• Adverse Events associated with tcPCO2 monitoring.

  1 week

• Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.

  7 days

• Compare ROC curves obtained by different extubation failure predictors

  7 days

Study Arms (1)

tcPCO2 measurement arm

EXPERIMENTAL

Patients will be monitored by tcPCO2 during spontaneous breathing trials

Procedure: tcPCO2 measurement

Interventions

tcPCO2 measurement PROCEDURE

tcPCO2 continuous monitoring during spontaneous breathing trials

tcPCO2 measurement arm

Eligibility Criteria

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

You may qualify if:

• \> 18 years old,
• ICU indicated
• invasive mechanical ventilation via orotracheal or nasotracheal intubation
• presence of criteria for initiation of the weaning process as stated on our ICU's protocol
• resolution of the disease leading to mechanical ventilation

You may not qualify if:

• mechanical ventilation during less than 24 hours
• Tracheotomy and tracheostomy at ICU admission
• Pregnancy
• Patient under legal protection
• Patient enrolled in another study regarding weaning or CO2 metabolism

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

CH Versailles

Le Chesnay, 78150, France

Location

Study Officials

• Henao-Brasseur Juliana

  CH Versailles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Care providers will be blinded of tcPCO2 measurements to avoid influencing extubation decisions.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study coordinator

Model Details: tcPCO2 will be monitored in all patients performing SBTs. The difference between maximal and initial tcPCO2 (ΔtcPCO2) in patients succeeding extubation will be compared with ΔtcPCO2 in patients failing extubation.

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: September 9, 2016
• Study Start: September 4, 2017
• Primary Completion: April 2, 2020
• Study Completion: August 31, 2020
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)