Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 (DELTA-CAPNO)

DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients

Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation; Prehospital Capnography Monitoring

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Quentin qc Carraro, md; Phone Number: +33 778817861; Email: quentin.carrar@gmail.com

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • Quentin Carraro
    • Contact: Quentin Carraro; Phone Number: +33 778817861; Email: quentin.carrar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients included are the major patients, intubated and ventilated in pre-hospital, transferred by the medical team to the University Hospital of Angers.

The ventilation settings are left to the caregiver's discretion, as is the purpose of Etco2.

Description

Inclusion Criteria:

• 18 years of age,
• Endotracheal intubation in pre-hospital and mechanical ventilation,
• Monitoring of Etco2 in pre-hospital settings

Exclusion Criteria:

• Identification of a chest wound blowing during pre-hospital care,
• No technical possibility for performing or analysing arterial sampling,
• Death during pre-hospital care,
• A person who has objected to the processing of his data for research at minimal risk and constraints (category 2) or for research on data, as well as persons subject to legal protection measures.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients	The main objective is therefore to determine the main risk factors to observe an alteration of the alveoarterial gradient in CO2, at the hospital care (fixed at 10 mmHg).	from january 2020 to april 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrahospital mortality	prognostic evidence of altered alveocapillary gradient on intrahospital mortality	from january 2020 to april 2021
Time of hospital admission	the prognosis of the finding of an altered alveocapillary gradient on the time of hospital admission	from january 2020 to april 2021
length of mecanical ventilation	the prognosis of the finding of an altered alveocapillary gradient on the duration of ventilation	from january 2020 to april 2021
Occurence of pneumonia	the prognosis of the finding of an altered alveocapillary gradient on the occurrence of pneumonia	from january 2020 to april 2021
Acute respiratory distress syndrom (ARDS)	the prognosis of the finding of an altered alveocapillary gradient on the occurrence of ARDS	from january 2020 to april 2021
Length of stay	the prognosis of the finding of an altered alveocapillary gradient on the length of stay	from january 2020 to april 2021
Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension	prognostic evidence of altered alveocapillary gradient, onset of an episode of intracranial hypertension, and intrahospital survival of severely traumatized patients (GCS < 9).	from january 2020 to april 2021

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Quentin qc Carraro, md, UH Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: capnography prehospital
• Other Study ID Numbers: UH Angers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No