Clinical trial NCT02894177: Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring for the Prediction of Extubation Failure in the ICU
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Keywords: E02.880.820.950
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.
timeFrame: 7 days
Secondary outcomes:
measure: Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)
timeFrame: 7 days
measure: Association between extubation decisions and ΔtcPCO2.
timeFrame: 1 week
measure: Adverse Events associated with tcPCO2 monitoring.
timeFrame: 1 week
measure: Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.
timeFrame: 7 days
measure: Compare ROC curves obtained by different extubation failure predictors
timeFrame: 7 days
measure: Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)
timeFrame: 7 days
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH Versailles
Study officials:
affiliation: CH Versailles
name: Henao-Brasseur Juliana
role: PRINCIPAL_INVESTIGATOR
References: