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

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04489615
Collaborator
(none)
200
Enrollment
1
Location
11.9
Anticipated Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients
    Actual Study Start Date :
    Jun 3, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    Jun 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients [from january 2020 to april 2021]

      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).

    Secondary Outcome Measures

    1. Intrahospital mortality [from january 2020 to april 2021]

      prognostic evidence of altered alveocapillary gradient on intrahospital mortality

    2. Time of hospital admission [from january 2020 to april 2021]

      the prognosis of the finding of an altered alveocapillary gradient on the time of hospital admission

    3. length of mecanical ventilation [from january 2020 to april 2021]

      the prognosis of the finding of an altered alveocapillary gradient on the duration of ventilation

    4. Occurence of pneumonia [from january 2020 to april 2021]

      the prognosis of the finding of an altered alveocapillary gradient on the occurrence of pneumonia

    5. Acute respiratory distress syndrom (ARDS) [from january 2020 to april 2021]

      the prognosis of the finding of an altered alveocapillary gradient on the occurrence of ARDS

    6. Length of stay [from january 2020 to april 2021]

      the prognosis of the finding of an altered alveocapillary gradient on the length of stay

    7. Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension [from january 2020 to april 2021]

      prognostic evidence of altered alveocapillary gradient, onset of an episode of intracranial hypertension, and intrahospital survival of severely traumatized patients (GCS < 9).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quentin Carraro Angers France 49100

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Quentin qc Carraro, md, UH Angers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT04489615
    Other Study ID Numbers:
    • UH Angers
    First Posted:
    Jul 28, 2020
    Last Update Posted:
    Dec 2, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Angers
    capnography prehospital

    Study Results

    No Results Posted as of Dec 2, 2020