Ventilator WeaningtcPCO2NCT02894177
Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring for the Prediction of Extubation Failure in the ICU
A study testing tcPCO2 measurement in people with Ventilator Weaning, run by Versailles Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- tcPCO2 measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
- Conditions
- Ventilator Weaning
- Being tested
- tcPCO2 measurement
- Keywords
- E02.880.820.950
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tcPCO2 measurementProcedure or surgery
tcPCO2 continuous monitoring during spontaneous breathing trials
| Study group | Role | What they receive |
|---|---|---|
| tcPCO2 measurement arm | Experimental | Patients will be monitored by tcPCO2 during spontaneous breathing trials Receives: Procedure: tcPCO2 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between maximum and initial tcPCO2 (ΔtcPCO2) 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
Measured: 7 days
Secondary outcomes (6)
Association between ΔtcPCO2 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.
Measured: 7 days
Association between extubation decisions and ΔtcPCO2.
Measured: 1 week
Adverse Events associated with tcPCO2 monitoring.
Measured: 1 week
Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.
Measured: 7 days
Compare ROC curves obtained by different extubation failure predictors
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
Measured: 7 days
Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start4 Sep 2017
- Primary completion2 Apr 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henao Juliana, Versailles Hospital
- Investigators
- Henao-Brasseur Juliana, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894177
- Sponsor's protocol ID
- P15/07_ tcPCO2
- Acronym
- tcPCO2
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2016
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02894177
- Acronym / sponsor ID
- tcPCO2 / P15/07_ tcPCO2
- Conditions
- Ventilator Weaning
- Keywords
- E02.880.820.950
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| tcPCO2 measurement arm | Experimental | Procedure: tcPCO2 measurementPatients will be monitored by tcPCO2 during spontaneous breathing trials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (5 listed)
- mechanical ventilation during less than 24 hours
- Tracheotomy and tracheostomy at ICU admission
- Pregnancy
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tcPCO2 measurementtcPCO2 continuous monitoring during spontaneous breathing trials | Procedure or surgery | tcPCO2 measurement arm |
Primary outcome
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
6 secondary outcomes
Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)
Time frame: 7 days
Association between extubation decisions and ΔtcPCO2.
Time frame: 1 week
Adverse Events associated with tcPCO2 monitoring.
Time frame: 1 week
Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.
Time frame: 7 days
Compare ROC curves obtained by different extubation failure predictors
Time frame: 7 days
Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henao-Brasseur Juliana principal investigator
CH Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tcPCO2 measurement in people with Ventilator Weaning, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.