Weaning FailureNCT06627686
Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury
An observational study of Weaning Failure, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study will be to measure the predictive power of the respiratory muscle determinants including The maximal inspiratory pressure, and central drive determinant including Airway occlusion pressure and ratio between them in weaning outcome of traumatic brain injury patients undergoing invasive mechanical… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Air way occlusion pressure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 5 Oct 2024
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients with Traumatic Brain Injury
Traumatic brain injury (closed type) patients who will be admitted to ICU and intubated and MV more than 24 hours will be included in this study.
Age from 18 to 65 years (male or female).
Fulfillment of Criteria of readiness for weaning off MV :
Resolution of the cause of respiratory insufficiency and MV. Stable hemodynamic profile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury Observational Study
The aim of this study will be to measure the predictive power of the respiratory muscle determinants including The maximal inspiratory pressure, and central drive determinant including Airway occlusion pressure and ratio between them in weaning outcome of traumatic brain injury patients undergoing invasive mechanical ventilation.
Read the detailed description
Before spontaneous breathing trials with a T-piece for 30 min with an FIO2 of 0.40, measurements will be performed for a 20-second period. Three parameters will be analyzed: PImax, P0.1, and P0.1/PImax. PImax and P0.1 will be obtained using a unidirectional valve method and a manovacuometer (Instrumentation Industries, Bethel Park, PA) attached to the airway.
The device will have a scale of 30 cm H2O with a 1 cm H2O interval, and will be designed to perform measurements at each 0.1 second. Prior to testing, all subjects will be on pressure support ventilation mode (12-20 cm H2O) and will not be on sedatives. The head of the subject's bed will be elevated to 45 degrees and the cuff of the artificial airway will be hyperinflated to prevent air leakage during measurement.
The subject will have the airway clear of secretions by suctioning with standard tracheal suction procedures after pre-oxygenation for 2 minutes with FIO2 of 1.0.
After a brief rest period, pre-oxygenation will be repeated. The subject will then be disconnected from mechanical ventilation and allowed to breathe spontaneously for 10 seconds before connecting the artificial airway to the manovacuometer when the subject will at functional residual capacity. The subject will continuously be monitored by pulse oximetry and electrocardiogram, and will have continual respiratory physiotherapist attention.
For the present study, respiratory drive (P0.1) will be calculated as an average of the measured inspiratory pressure 0.1 s after the initiation of the inspiration for the first 3 cycles, and P0.1/PImax as the ratio of absolute values of P0.1 and PImax. The subjects will not coached for the maneuver. Thresholds for the 3 parameters will be calculated from their respective receiver operating characteristic (ROC) curves. Values more negative than -25 cm H2Owere used to predict successful weaning.
Weaning will be considered successful if spontaneous breathing will sustained for 48 hours after withdrawal from mechanical ventilation.
The trial will stopped if at least one of the following intolerance criteria present: SaO2 less than 90% or PaO2 less than 60 mm Hg with FIO2 greater than 0.4; PaCO2 greater than mm Hg or increased by 8 mm Hg or more; arterial pH less than 7.33 or decreased by 0.07 or more; respiratory rate greater than 35 breaths/ min or increased by 50% for 5 min or longer; heart rate greater than 140 beats/min or a sustained increase or decrease in 20%; mean blood pressure greater than 130mmHg or less than 70mmHg; or presence of agitation, diaphoresis, disorientation, or depressed mental status.
The subjects who will demonstrate one of these signs during the spontaneous breathing trial or within 48 hours after the discontinuation from mechanical ventilation will be considered not weaned and will returne to ventilator support.
Before being submitted to spontaneous breathing trials (SBTs) of 2 hours patients will have the tracheal P 0.1 and the PImax measured; P 0.1/PImax ratio will then be calculated.
Traditional thresholds will be adopted for the 3 parameters. Tracheal P 0.1 will be measured in pressure support ventilation, with pressure support in 7 cm H2O and positive end expiratory pressure in 5 cm H2O. At least 3 measurements, separated by an interval of not less than 15 seconds, will be obtained, and the mean value will be used for analysis. Tracheal P 0.1 values less than 4.2 cm H2O will be used to predict successful weaning.
P 0.1/PImax ratio will be obtained through the division of tracheal P 0.1 by PImax, and because both of them, in reality, are negative pressures, the result will expressed in positive values. Values smaller than 0.14 will be used to predict successful weaning.
4- Patients who will pass SBT without deterioration will extubated and receive oxygen through Venturi mask 40%. However, SBT failure will be considered if the patient develop a decreased level of consciousness, diaphoresis, RR>35 breaths/min, hemodynamic instability (heart rate>140, systolic blood pressure>180 or <90 mmHg) or signs of increased work of breathing.
- Conditions
- Weaning Failure
- Being tested
- Air way occlusion pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air way occlusion pressureDiagnostic test
Also called Maximal inspiratory pressure
Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients with Traumatic Brain Injury
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury | Air way occlusion pressure and maximum inspiratory pressure Receives: Diagnostic Test: Air way occlusion pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensetivity, specifity, predictive values, and accuracy of Maximal inspiratory pressure, Airway occlusion pressure and their ratio will be determined by ROC curve.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Ali Rashad Ahmed Abd El Bary, Benha University
- Investigators
- Ali Rashad, MBBCH, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627686
- Sponsor's protocol ID
- MS 23_7_2023
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury Observational Study
- ClinicalTrials.gov ID
- NCT06627686
- Acronym / sponsor ID
- MS 23_7_2023
- Conditions
- Weaning Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 4 Oct 2024 (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 aim of this study will be to measure the predictive power of the respiratory muscle determinants including The maximal inspiratory pressure, and central drive determinant including Airway occlusion pressure and ratio between them in weaning outcome of traumatic brain injury patients undergoing invasive mechanical ventilation.
Detailed description
Before spontaneous breathing trials with a T-piece for 30 min with an FIO2 of 0.40, measurements will be performed for a 20-second period. Three parameters will be analyzed: PImax, P0.1, and P0.1/PImax. PImax and P0.1 will be obtained using a unidirectional valve method and a manovacuometer (Instrumentation Industries, Bethel Park, PA) attached to the airway.
The device will have a scale of 30 cm H2O with a 1 cm H2O interval, and will be designed to perform measurements at each 0.1 second. Prior to testing, all subjects will be on pressure support ventilation mode (12-20 cm H2O) and will not be on sedatives. The head of the subject's bed will be elevated to 45 degrees and the cuff of the artificial airway will be hyperinflated to prevent air leakage during measurement.
The subject will have the airway clear of secretions by suctioning with standard tracheal suction procedures after pre-oxygenation for 2 minutes with FIO2 of 1.0.
After a brief rest period, pre-oxygenation will be repeated. The subject will then be disconnected from mechanical ventilation and allowed to breathe spontaneously for 10 seconds before connecting the artificial airway to the manovacuometer when the subject will at functional residual capacity. The subject will continuously be monitored by pulse oximetry and electrocardiogram, and will have continual respiratory physiotherapist attention.
For the present study, respiratory drive (P0.1) will be calculated as an average of the measured inspiratory pressure 0.1 s after the initiation of the inspiration for the first 3 cycles, and P0.1/PImax as the ratio of absolute values of P0.1 and PImax. The subjects will not coached for the maneuver. Thresholds for the 3 parameters will be calculated from their respective receiver operating characteristic (ROC) curves. Values more negative than -25 cm H2Owere used to predict successful weaning.
Weaning will be considered successful if spontaneous breathing will sustained for 48 hours after withdrawal from mechanical ventilation.
The trial will stopped if at least one of the following intolerance criteria present: SaO2 less than 90% or PaO2 less than 60 mm Hg with FIO2 greater than 0.4; PaCO2 greater than mm Hg or increased by 8 mm Hg or more; arterial pH less than 7.33 or decreased by 0.07 or more; respiratory rate greater than 35 breaths/ min or increased by 50% for 5 min or longer; heart rate greater than 140 beats/min or a sustained increase or decrease in 20%; mean blood pressure greater than 130mmHg or less than 70mmHg; or presence of agitation, diaphoresis, disorientation, or depressed mental status.
The subjects who will demonstrate one of these signs during the spontaneous breathing trial or within 48 hours after the discontinuation from mechanical ventilation will be considered not weaned and will returne to ventilator support.
Before being submitted to spontaneous breathing trials (SBTs) of 2 hours patients will have the tracheal P 0.1 and the PImax measured; P 0.1/PImax ratio will then be calculated.
Traditional thresholds will be adopted for the 3 parameters. Tracheal P 0.1 will be measured in pressure support ventilation, with pressure support in 7 cm H2O and positive end expiratory pressure in 5 cm H2O. At least 3 measurements, separated by an interval of not less than 15 seconds, will be obtained, and the mean value will be used for analysis. Tracheal P 0.1 values less than 4.2 cm H2O will be used to predict successful weaning.
P 0.1/PImax ratio will be obtained through the division of tracheal P 0.1 by PImax, and because both of them, in reality, are negative pressures, the result will expressed in positive values. Values smaller than 0.14 will be used to predict successful weaning.
4- Patients who will pass SBT without deterioration will extubated and receive oxygen through Venturi mask 40%. However, SBT failure will be considered if the patient develop a decreased level of consciousness, diaphoresis, RR>35 breaths/min, hemodynamic instability (heart rate>140, systolic blood pressure>180 or <90 mmHg) or signs of increased work of breathing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury | – | Diagnostic Test: Air way occlusion pressureAir way occlusion pressure and maximum inspiratory pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients with Traumatic Brain Injury
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 |
|---|---|---|
| Air way occlusion pressureAlso: Maximal inspiratory pressurePredictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients with Traumatic Brain Injury | Diagnostic test | Traumatic brain injury |
Primary outcome
Sensetivity, specifity, predictive values, and accuracy of Maximal inspiratory pressure, Airway occlusion pressure and their ratio will be determined by ROC curve.
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Ali Rashad, MBBCH principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ali Rashad, MBBCH (201018020543, draliali123456@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensetivity, specifity, predictive values, and accuracy of Maximal inspiratory pressure, Airway occlusion pressure and their ratio will be determined by ROC curve. (time frame: One day). 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 4 Oct 2024.