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

NCT04819984 | Unknown

• 1 other identifier: D20-P030
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Brain Injury

Outcome Measures

Primary Outcomes (1)

• Predictive value (PPV and Se, Sp) of the PtCO2 variation for exhumation failure

  extubation failure is defined by : 1. the need to reintubate the patient in the first 48 hours after extubation 2. 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 3. death in the first 48 hours following extubation

  48 hours after programmed extubation of the patient

Secondary Outcomes (3)

• Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements

  during ventilatory weaning test

• Presence of a diaphragmatic dysfunction during ventilatory weaning test

  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

  during hospitalization period in intensive care unit from the procedure time to discharge trough study completion (1 year)

Study Arms (1)

Continuous PtC02 evaluation

EXPERIMENTAL

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

Device: TCM5 device (Radiometer) for PtC02 continuous measurement

Interventions

TCM5 device (Radiometer) for PtC02 continuous measurement DEVICE

Evaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece)

Continuous PtC02 evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The measured values of continuous PtC02 will not be disclosed to care provider or participant during the ventilatory weaning test
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients meeting the inclusion criteria will be included in the trial

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 29, 2021
• Study Start: April 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 29, 2021

Record last verified: 2021-03