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

Is Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring During Spontaneous Breathing Trials Useful to Predict Extubation Failure in Mechanically Ventilated Patients in the ICU?

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Weaning
• Intervention / Treatment: Procedure: tcPCO2 measurement

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • CH Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tcPCO2 measurement arm; Patients will be monitored by tcPCO2 during spontaneous breathing trials	Procedure: tcPCO2 measurement; tcPCO2 continuous monitoring during spontaneous breathing trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)	Different post-extubation ventilation protocols may include preventive non invasive ventilation or 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	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	7 days
Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)		7 days

Collaborators and Investigators

• Sponsor: Versailles Hospital
• Investigators: Principal Investigator: Henao-Brasseur Juliana, CH Versailles

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 14, 2016
• First Submitted That Met QC Criteria: September 4, 2016
• First Posted (Estimated): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: E02.880.820.950
• Other Study ID Numbers: P15/07_ tcPCO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No