Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitorin... | NCT02894177

Studies
Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring for the Prediction of Extubation Failure in the ICU

NCT02894177

Sponsor

Versailles Hospital

Status

Completed

Last Update Posted

Oct 17, 2023Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Ventilator Weaning

Interventions

tcPCO2 measurement

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2017Actual

Primary Completion Date

Apr 2, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Aug 14, 2016

First Submission Date that Met QC Criteria

Sep 4, 2016

First Posted Date

Sep 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2023

Last Update Posted Date

Oct 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tcPCO2 measurement arm	Experimental	Patients will be monitored by tcPCO2 during spontaneous breathing trials	Procedure: tcPCO2 measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tcPCO2 measurement	Procedure	tcPCO2 continuous monitoring during spontaneous breathing trials	tcPCO2 measurement arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	7 days

Secondary Outcomes

Measure	Description	Time Frame
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.	7 days
Association between extubation decisions and ΔtcPCO2.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henao-Brasseur Juliana	CH Versailles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Versailles		Le Chesnay		78150	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.