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

NCT ID: NCT02894177

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Ventilator Weaning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Care providers will be blinded of tcPCO2 measurements to avoid influencing extubation decisions.

Study Groups

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tcPCO2 measurement arm

Patients will be monitored by tcPCO2 during spontaneous breathing trials

Group Type EXPERIMENTAL

tcPCO2 measurement

Intervention Type PROCEDURE

tcPCO2 continuous monitoring during spontaneous breathing trials

Interventions

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tcPCO2 measurement

tcPCO2 continuous monitoring during spontaneous breathing trials

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henao Juliana

study coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henao-Brasseur Juliana

Role: PRINCIPAL_INVESTIGATOR

CH Versailles

Locations

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CH Versailles

Le Chesnay, , France

Site Status

Countries

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France

Other Identifiers

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P15/07_ tcPCO2

Identifier Type: -

Identifier Source: org_study_id

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