Ventilator Weaning
Conditions
Keywords
E02.880.820.950
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.
Interventions
PROCEDUREtcPCO2 measurement
tcPCO2 continuous monitoring during spontaneous breathing trials
Sponsors
Versailles Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Care providers will be blinded of tcPCO2 measurements to avoid influencing extubation decisions.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Association between extubation decisions and ΔtcPCO2. | 1 week | — |
| Adverse Events associated with tcPCO2 monitoring. | 1 week | — |
| 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. |
| 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 |
| Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT) | 7 days | — |
| Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve. | 7 days | — |
Countries
France
Outcome results
None listed