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Impact of Continuous Monitoring of PtC02 on Ventilatory Weaning in Neuro-injured Patients (CO2MBAWA)

Primary Purpose

Acute Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TCM5 device (Radiometer) for PtC02 continuous measurement
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • major patients (>18 years)
  • admitted in ICU for an acute brain injury defined by a Glasgow Coma Scale < 8 and the presence of a cerebral lesion identified on a referent Tomodensitometry (TDM) or Magnetic Resonance Imaging (MRI)
  • requiring mechanical ventilation during >48 hours
  • eligible for a ventilatory weaning test

Exclusion Criteria:

  • preexisting neurologic evolutive or degenerative affection or preexisting diaphragmatic dysfunction
  • preexisting decision of therapeutic limitation
  • impossibility to collect an informed consent
  • patients aged <18 years
  • pregnancy
  • mental illness
  • impossibility for the subject to have a good comprehension of the study
  • lack of health insurance coverage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Continuous PtC02 evaluation

    Arm Description

    Continuous PtC02 measured by TCM5 monitor during ventilatory weaning test of 30 minutes when available

    Outcomes

    Primary Outcome Measures

    Predictive value (PPV and Se, Sp) of the PtCO2 variation for exhumation failure
    extubation failure is defined by : the need to reintubate the patient in the first 48 hours after extubation the need of non-invasive ventilation (NIV) in the first 48 hours after programmed extubation for a respiratory distress manifestation (therapeutic NIV) or in the first 7 days if requiring of prophylactic NIV during the first 48 hours death in the first 48 hours following extubation

    Secondary Outcome Measures

    Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements
    gradient PtC02-PaC02
    Presence of a diaphragmatic dysfunction during ventilatory weaning test
    diaphragmatic dysfunction defined by echo assessment with the criteria of Boussuges (Diaphragmatic excursion < 1cm for men or < 0,9 cm for women or a diaphragmatic thickening fraction < 30 %)
    presence of respiratory and non respiratory complications during a period from extubation to the hospital discharge
    lung infection, pleural effusion, ARDS defined by Berlin Criteria, atelectasia, other diaphragmatic dysfunction Cardiac complications (infarctus, ischemia, atrial fibrillation) septic schock or an other aetiology of schock

    Full Information

    First Posted
    February 4, 2021
    Last Updated
    March 25, 2021
    Sponsor
    Centre Hospitalier St Anne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04819984
    Brief Title
    Impact of Continuous Monitoring of PtC02 on Ventilatory Weaning in Neuro-injured Patients
    Acronym
    CO2MBAWA
    Official Title
    Evaluation of the Impact of Continuous Monitoring of PtC02 Measurements During Weaning From Invasive Ventilation in Neuro-injured Critical Care Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    February 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier St Anne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators propose to study the value of non invasive continuous transcutaneous PtC02 monitoring for ventilatory withdrawal guidance in neuro-injured patients and to predict the risk of extubation failure in this category of patients, particularly at risk of re-intubation.
    Detailed Description
    Extubation is part of the daily routine in intensive care and intensive care units. If the procedures for weaning from mechanical ventilation are well supervised by the establishment, in particular, of standardized treatment protocols, they nevertheless remain technical procedures at risk and are associated with significant morbidity and mortality. Extubation, defined by the withdrawal of the intubation probe, is to be distinguished from the period known as ventilatory "weaning" or "ventilation" which is represented by the separation of the patient from the invasive mechanical ventilation device. These 2 successive phases (deventilation then extubation) must be anticipated as best as possible by the intensivist in order to detect the risk factors and complications inherent in one or the other of the stages. A patient can thus be ventilable but not extubable and vice versa. Extubation failure can be defined as the need for early reintubation within 48-72 hours of scheduled intensive care extubation. This definition takes into account the contribution of non-invasive ventilation (NIV) that can be applied in the direct consequences of extubation. The risk factors specific to failure of extubation are well identified in the literature and differ from those associated with failure of ventilatory weaning. These risk factors are multiple but are represented in particular by obstruction of the airways, ineffectiveness of cough or bronchial congestion, swallowing disturbances and disturbances of consciousness among others. Monitoring of transcutaneous pressure in CO2 (PtCO2) has been developed over the past twenty years as a reflection of arterial pressure in CO2 (PaCO2). To date, this type of monitoring has been developed mainly in neonatal care due to its non-invasive nature. This continuous monitoring could be an interesting tool in the evaluation of the gas exchange of the patient under mechanical ventilation, in particular in a medical or surgical resuscitation environment. This tool could thus make it possible to participate in the prediction of extubation failure in medical intensive care or general surgery during ventilatory weaning tests. There is indeed a good correlation between PaC02 and PtC02 in the intensive care patient population for PaC02 values <60 mmHg. We therefore propose to study the benefit of using transcutaneous PtC02 monitoring for guiding ventilatory weaning in neuro-injured patients and predicting the risk of extubation failure in this category of patients, particularly at risk of re-intubation. The main objective of the study carried out is therefore to assess the predictive value of the observed variation in PtCO2 during a spontaneous ventilation weaning test in a population of neuro-resuscitation patients at high risk of reintubation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Brain Injury

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All patients meeting the inclusion criteria will be included in the trial
    Masking
    None (Open Label)
    Masking Description
    The measured values of continuous PtC02 will not be disclosed to care provider or participant during the ventilatory weaning test
    Allocation
    N/A
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous PtC02 evaluation
    Arm Type
    Experimental
    Arm Description
    Continuous PtC02 measured by TCM5 monitor during ventilatory weaning test of 30 minutes when available
    Intervention Type
    Device
    Intervention Name(s)
    TCM5 device (Radiometer) for PtC02 continuous measurement
    Intervention Description
    Evaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece)
    Primary Outcome Measure Information:
    Title
    Predictive value (PPV and Se, Sp) of the PtCO2 variation for exhumation failure
    Description
    extubation failure is defined by : the need to reintubate the patient in the first 48 hours after extubation the need of non-invasive ventilation (NIV) in the first 48 hours after programmed extubation for a respiratory distress manifestation (therapeutic NIV) or in the first 7 days if requiring of prophylactic NIV during the first 48 hours death in the first 48 hours following extubation
    Time Frame
    48 hours after programmed extubation of the patient
    Secondary Outcome Measure Information:
    Title
    Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements
    Description
    gradient PtC02-PaC02
    Time Frame
    during ventilatory weaning test
    Title
    Presence of a diaphragmatic dysfunction during ventilatory weaning test
    Description
    diaphragmatic dysfunction defined by echo assessment with the criteria of Boussuges (Diaphragmatic excursion < 1cm for men or < 0,9 cm for women or a diaphragmatic thickening fraction < 30 %)
    Time Frame
    at the beginning and at the end of the ventilatory weaning test (From the beginning of the ventilatory weaning test at 0 minute to the end 30 minutes later)
    Title
    presence of respiratory and non respiratory complications during a period from extubation to the hospital discharge
    Description
    lung infection, pleural effusion, ARDS defined by Berlin Criteria, atelectasia, other diaphragmatic dysfunction Cardiac complications (infarctus, ischemia, atrial fibrillation) septic schock or an other aetiology of schock
    Time Frame
    during hospitalization period in intensive care unit from the procedure time to discharge trough study completion (1 year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: major patients (>18 years) admitted in ICU for an acute brain injury defined by a Glasgow Coma Scale < 8 and the presence of a cerebral lesion identified on a referent Tomodensitometry (TDM) or Magnetic Resonance Imaging (MRI) requiring mechanical ventilation during >48 hours eligible for a ventilatory weaning test Exclusion Criteria: preexisting neurologic evolutive or degenerative affection or preexisting diaphragmatic dysfunction preexisting decision of therapeutic limitation impossibility to collect an informed consent patients aged <18 years pregnancy mental illness impossibility for the subject to have a good comprehension of the study lack of health insurance coverage

    12. IPD Sharing Statement

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    Impact of Continuous Monitoring of PtC02 on Ventilatory Weaning in Neuro-injured Patients

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