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Clinical Trials/NCT02894177
NCT02894177
Completed
Not Applicable

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

Versailles Hospital1 site in 1 country130 target enrollmentSeptember 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator Weaning
Sponsor
Versailles Hospital
Enrollment
130
Locations
1
Primary Endpoint
Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 4, 2017
End Date
August 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Henao Juliana

study coordinator

Versailles Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 7 days

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

Secondary Outcomes

  • Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)(7 days)
  • 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)

Study Sites (1)

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