Transcutaneous PCO2 Assessment During Intubation in ICU (C-TOP)

October 25, 2019 updated by: Rennes University Hospital
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Centre Hospitalier Universitaire de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU patients requiring intubation

Description

Inclusion Criteria:

  • Adult patient 18 years of age or older
  • Requiring intubation in Resuscitation

Exclusion Criteria:

  • Contraindication to orotracheal intubation
  • Intubation in a respiratory or cardiocirculatory arrest situation
  • Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration
  • Major Incapable
  • Opposition of the patient or his relatives to the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Oxygen
preoxygenation methods : Standard Oxygen
Procedure: PtcCO2 measure during intubation
Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature
High flow Oxygen
preoxygenation methods : High flow Oxygen
Procedure: PtcCO2 measure during intubation
Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature
Non invasive ventilation
preoxygenation methods : Non invasive ventilation
Procedure: PtcCO2 measure during intubation
Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous carbon dioxide partial pressure variation during intubation
Time Frame: 4 hours after intubation (the day of inclusion)
Transcutaneous carbon dioxide partial pressure (TcPO2) variation during intubation in ICU and within 4 hours after intubation
4 hours after intubation (the day of inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Aurélien FREROU, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2018

Primary Completion (Actual)

March 16, 2019

Study Completion (Actual)

April 13, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 35RC18_3030_C-TOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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