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

Ventilator Weaning Clinical Trial

— tcPCO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894177
• Other study ID #: P15/07_ tcPCO2
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2023
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 31, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilator Weaning

Intervention

Procedure:
• tcPCO2 measurement
tcPCO2 continuous monitoring during spontaneous breathing trials

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between maximum and initial tcPCO2 (?tcPCO2) 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	Association between ?tcPCO2 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
Secondary	Association between extubation decisions and ?tcPCO2.		1 week
Secondary	Adverse Events associated with tcPCO2 monitoring.		1 week
Secondary	Optimal ?tcPCO2 threshold to predict extubation failure by a ROC curve.		7 days
Secondary	Compare ROC curves obtained by different extubation failure predictors	ROC curves obtained with: usual SBT failure criteria; deltatcPCO2 alone; usual criteria and ?tcPCO2 combined; shallow breathing index; shallow breathing index and ?tcPCO2 combined; ?tcPCO2, shallow breathing index and usual SBT failure criteria combined	7 days
Secondary	Determine if ?tcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)		7 days