Weaning FailureNCT05431036
Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.
An observational study of Weaning Failure, run by Assiut University.
Trial summary
The purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- transthoracic ultrasonography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group will be mechanically ventilated for at least 48 hours. Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines and assessment of the three parameters which is Rapid shallow breathing index ( RSBI), lung ultrasound score( LUS) and Diaphragmatic ultrasound (DUS) will be done for predicting weaning success.
Who may be able to join
- Patients more than18 years old.
- All patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (RICU)
- Patients fullfiled the criteria of readiness to wean according to European Respiratory Society guidelines (ERS)
Who cannot join
- Patients with neuromuscular disease or diaphragmatic paralysis.
- Patients with tracheostomy.
- Patients who undergone surgical operations especially abdominal and thoracic operation.
- Patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ICT), third trimester of pregnancy).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of a Combined Model of Lung Aeration Score and Diaphragmatic Indices by Transthoracic Ultrasonography in Predicting Weaning Success in Critically Ill Patients.
The purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success
Read the detailed description
Assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .
- Conditions
- Weaning Failure
- Being tested
- transthoracic ultrasonography
- Keywords
- LUS, DUS, RSBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic ultrasonographyDevice
- The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern and Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points)
- The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness and motion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of lung aeration by lung ultrasound score using MEDESION SONOACE R3 portable ultrasound apparatus in patients ready to be weaned from mechanical ventilation (MV) as a predictor of weaning success.
The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern using the convex probe (MEDESION SONOACE R3 portable ultrasound, Korea 2010). (normal aeration, LUS = 0);( moderate loss of lung aeration (multiple, well-defined B lines), LUS = 1);( severe loss of lung aeration (multiple coalescent B lines), LUS = 2); (lung consolidation, LUS = 3).Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points).
Measured: baseline
Assessment of diaphragmatic thickness by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness by M-Mode Using the high frequency linear probe of 7.5 MHz.This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. DT difference (DTD) will be calculated by subtracting The Diaphragm thickening fraction (DTF) will calculated as: DTD/(DT at end-expiration) × 100%
Measured: baseline
Assessment of diaphragmatic motion by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
The diaphragmatic ultrasound will performed for assessment of diaphragmatic motion by M-mode using the curvilinear low frequency probe (5 MHz).This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. Diaphragmatic excursion (DE) will identified and measured. DE amplitude will measured on the vertical axis by tracing from the baseline to the point of maximum height of inspiration on the graph.
Measured: baseline
Secondary outcomes (1)
Compare between sonographic lung aeration assessment, diaphragmatic indices and rapid shallow breathing index(RSBI) as predictors for results of weaning from mechanical ventilation(MV)
Compare between sonographic lung aeration assessment, diaphragmatic indices and RSBI as predictors for results of weaning from MV and showing the predictive value for which parameter to predict weaning sucess alone or combining all three parameters together.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohammed Taghyan, Assiut University
- Investigators
- Alaa M Taghyan, Ass.Lecturer, Principal investigator, Chest department at Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431036
- Sponsor's protocol ID
- lung US in ICU patient
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
PubMed 23344830Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
PubMed 22584759Li S, Chen Z, Yan W. Application of bedside ultrasound in predicting the outcome of weaning from mechanical ventilation in elderly patients. BMC Pulm Med. 2021 Jul 9;21(1):217. doi: 10.1186/s12890-021-01605-4.
PubMed 34243739
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined Model of Lung Aeration Score and Diaphragmatic Indices by Transthoracic Ultrasonography in Predicting Weaning Success in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT05431036
- Acronym / sponsor ID
- lung US in ICU patient
- Conditions
- Weaning Failure
- Keywords
- LUS, DUS, RSBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Jun 2022 (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 purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success
Detailed description
Assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will be mechanically ventilated for at least 48 hours. Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines and assessment of the three parameters which is Rapid shallow breathing index ( RSBI), lung ultrasound score( LUS) and Diaphragmatic ultrasound (DUS) will be done for predicting weaning success.
Key inclusion criteria (3 listed)
- Patients more than18 years old.
- All patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (RICU)
- Patients fullfiled the criteria of readiness to wean according to European Respiratory Society guidelines (ERS)
Key exclusion criteria (4 listed)
- Patients with neuromuscular disease or diaphragmatic paralysis.
- Patients with tracheostomy.
- Patients who undergone surgical operations especially abdominal and thoracic operation.
- Patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ICT), third trimester of 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 |
|---|---|---|
| transthoracic ultrasonography1. The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern and Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points) 2. The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness and motion. | Device | – |
Primary outcome
Assessment of lung aeration by lung ultrasound score using MEDESION SONOACE R3 portable ultrasound apparatus in patients ready to be weaned from mechanical ventilation (MV) as a predictor of weaning success.
Time frame: baseline
The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern using the convex probe (MEDESION SONOACE R3 portable ultrasound, Korea 2010). (normal aeration, LUS = 0);( moderate loss of lung aeration (multiple, well-defined B lines), LUS = 1);( severe loss of lung aeration (multiple coalescent B lines), LUS = 2); (lung consolidation, LUS = 3).Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points).
Assessment of diaphragmatic thickness by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
Time frame: baseline
The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness by M-Mode Using the high frequency linear probe of 7.5 MHz.This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. DT difference (DTD) will be calculated by subtracting The Diaphragm thickening fraction (DTF) will calculated as: DTD/(DT at end-expiration) × 100%
Assessment of diaphragmatic motion by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
Time frame: baseline
The diaphragmatic ultrasound will performed for assessment of diaphragmatic motion by M-mode using the curvilinear low frequency probe (5 MHz).This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. Diaphragmatic excursion (DE) will identified and measured. DE amplitude will measured on the vertical axis by tracing from the baseline to the point of maximum height of inspiration on the graph.
1 secondary outcome
Compare between sonographic lung aeration assessment, diaphragmatic indices and rapid shallow breathing index(RSBI) as predictors for results of weaning from mechanical ventilation(MV)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 23344830Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
- Background: PubMed 22584759Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
- Background: PubMed 34243739Li S, Chen Z, Yan W. Application of bedside ultrasound in predicting the outcome of weaning from mechanical ventilation in elderly patients. BMC Pulm Med. 2021 Jul 9;21(1):217. doi: 10.1186/s12890-021-01605-4.
- 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.
Alaa M Taghyan, Ass.Lecturer principal investigator
Chest department at Assuit university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by Assiut University.
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 3 inclusion and 4 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 4 Oct 2022. 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?
Contact Alaa M Taghyan, master (01093093050, alaataghyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of lung aeration by lung ultrasound score using MEDESION SONOACE R3 portable ultrasound apparatus in patients ready to be weaned from mechanical ventilation (MV) as a predictor of weaning success. (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431036, which also lists 3 linked publications.
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 2022.