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Completed

NCT Number: NCT02894177

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

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Key information

Conditions

Ventilator Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Versailles

Le Chesnay, 78150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tcPCO2 measurement

Procedure

tcPCO2 continuous monitoring during spontaneous breathing trials

Primary outcomes

  1. 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

  1. Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)

    Time frame: 7 days

    Different post-extubation ventilation protocols may include preventive non invasive ventilation or Optiflow.

  2. Association between extubation decisions and ΔtcPCO2.

    Time frame: 1 week

  3. Adverse Events associated with tcPCO2 monitoring.

    Time frame: 1 week

  4. Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.

    Time frame: 7 days

  5. Compare ROC curves obtained by different extubation failure predictors

    Time frame: 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

  6. Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study title

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

Acronym: tcPCO2

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2016
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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