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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888430
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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Brief Summary:
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Condition or disease Intervention/treatment
Intubation in ICU Procedure: PtcCO2 measure during intubation

Detailed Description:
Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.
Study Design
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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcutaneous PCO2 Assessment During Intubation in ICU
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : March 16, 2019
Actual Study Completion Date : April 13, 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
ICU patients requiring intubation
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888430


Locations
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France
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Aurélien FREROU, MD Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03888430    
Other Study ID Numbers: 35RC18_3030_C-TOP
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Transcutaneous PCO2
Preoxygenation
Post-intubation hypotension
ICU