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

Evaluation of the Impact of Continuous Monitoring of PtC02 Measurements During Weaning From Invasive Ventilation in Neuro-injured Critical Care Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Brain Injury
• Intervention / Treatment: Device: TCM5 device (Radiometer) for PtC02 continuous measurement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Continuous PtC02 evaluation; Continuous PtC02 measured by TCM5 monitor during ventilatory weaning test of 30 minutes when available	Device: TCM5 device (Radiometer) for PtC02 continuous measurement; Evaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours after programmed extubation of the patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements	gradient PtC02-PaC02	during ventilatory weaning test
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 %)	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)
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	during hospitalization period in intensive care unit from the procedure time to discharge trough study completion (1 year)

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: D20-P030

Drug and device information, study documents

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