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

Not Applicable

Completed

• Conditions: Ventilator Weaning
• Interventions: Procedure: tcPCO2 measurement

• Registration Number: NCT02894177
• Lead Sponsor: Versailles Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-14
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Study Start: 2017-09-04
• Primary Completion: 2020-04-02
• Study Completion: 2020-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• > 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tcPCO2 measurement arm	tcPCO2 measurement	Patients will be monitored by tcPCO2 during spontaneous breathing trials

Primary Outcome Measures

Name	Time	Method
Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.	7 days	Extubation failure: need for reintubation, rescue non invasive ventilation or death within 7 days following extubation

Secondary Outcome Measures

Name	Time	Method
Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)	7 days	Different post-extubation ventilation protocols may include preventive non invasive ventilation or Optiflow.
Adverse Events associated with tcPCO2 monitoring.	1 week
Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)	7 days
Association between extubation decisions and ΔtcPCO2.	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	ROC curves obtained with: * usual SBT failure criteria; * deltatcPCO2 alone; * usual criteria and ΔtcPCO2 combined; * shallow breathing index; * shallow breathing index and ΔtcPCO2 combined; * ΔtcPCO2, shallow breathing index and usual SBT failure criteria combined

Trial Locations

Locations (1)

CH Versailles; 🇫🇷 Le Chesnay, France