Acute Brain InjuryCO2MBAWANCT04819984
Impact of Continuous Monitoring of PtC02 on Ventilatory Weaning in Neuro-injured Patients
A study testing TCM5 device (Radiometer) for PtC02 continuous measurement in people with Acute Brain Injury, run by Centre Hospitalier St Anne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- TCM5 device (Radiometer) for PtC02 continuous measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Brain Injury
- Being tested
- TCM5 device (Radiometer) for PtC02 continuous measurement
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM5 device (Radiometer) for PtC02 continuous measurementDevice
Evaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece)
| Study group | Role | What they receive |
|---|---|---|
| Continuous PtC02 evaluation | Experimental | Continuous PtC02 measured by TCM5 monitor during ventilatory weaning test of 30 minutes when available Receives: Device: TCM5 device (Radiometer) for PtC02 continuous measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after programmed extubation of the patient
Secondary outcomes (3)
Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements
gradient PtC02-PaC02
Measured: 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 %)
Measured: 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
Measured: during hospitalization period in intensive care unit from the procedure time to discharge trough study completion (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients meeting the inclusion criteria will be included in the trial
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819984
- Sponsor's protocol ID
- D20-P030
- Acronym
- CO2MBAWA
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Continuous Monitoring of PtC02 Measurements During Weaning From Invasive Ventilation in Neuro-injured Critical Care Patients
- ClinicalTrials.gov ID
- NCT04819984
- Acronym / sponsor ID
- CO2MBAWA / D20-P030
- Conditions
- Acute Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients meeting the inclusion criteria will be included in the trial
| Arm | Type | Receives |
|---|---|---|
| Continuous PtC02 evaluation | Experimental | Device: TCM5 device (Radiometer) for PtC02 continuous measurementContinuous PtC02 measured by TCM5 monitor during ventilatory weaning test of 30 minutes when available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM5 device (Radiometer) for PtC02 continuous measurementEvaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece) | Device | Continuous PtC02 evaluation |
Primary outcome
Predictive value (PPV and Se, Sp) of the PtCO2 variation for exhumation failure
Time frame: 48 hours after programmed extubation of the patient
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
3 secondary outcomes
Difference and variation between PtC02 and PaC02 (obtained on blood gases) measurements
Time frame: during ventilatory weaning test
Presence of a diaphragmatic dysfunction during ventilatory weaning test
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)
presence of respiratory and non respiratory complications during a period from extubation to the hospital discharge
Time frame: during hospitalization period in intensive care unit from the procedure time to discharge trough study completion (1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TCM5 device (Radiometer) for PtC02 continuous measurement in people with Acute Brain Injury, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value (PPV and Se, Sp) of the PtCO2 variation for exhumation failure (time frame: 48 hours after programmed extubation of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.