C-TOP: Transcutaneous PCO2 Assessment During Intubation in ICU

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03888430
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 18.6

Study Details

Study Description

Brief Summary

PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Condition or Disease	Intervention/Treatment	Phase
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

• 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: Mar 16, 2019
• Actual Study Completion Date: Apr 13, 2019

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Transcutaneous carbon dioxide partial pressure variation during intubation [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Rennes	Rennes		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03888430
• Other Study ID Numbers: 35RC18_3030_C-TOP
• First Posted: Mar 25, 2019
• Last Update Posted: Oct 28, 2019
• Last Verified: Oct 1, 2019

• 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

Study Results

No Results Posted as of Oct 28, 2019