Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated PatientsNCT06685224
Prediction of Weaning Outcome From Mechanical Ventilation Using Ultrasound
An observational study of Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients, run by Tanta University.
Trial summary
Examine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients
- What is being tested?
- Ultrasound Assessment of the aeration of lung tissue and Parasternal Intercostal Muscle Thickness
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tanta University Hospitals
Who may be able to join
- Mechanically ventilated patients will be included in the study when the underlying disease that had required intubation is considered by the attending physician as reversed and after fulfilling the criteria of weaning (alertness, and Adequate gas exchange, normal pH levels, low and stable doses of vasoactive drugs, normal electrolyte levels, and a rapid shallow breathing index (RSBI) of 105 breaths per minute per liter or lower ) rendering the patient eligible to a first SBT.
Who cannot join
- Exclusion criteria include patients aged < 21yrs , patients with tracheostomy, paraplegia with medullar level above T8, cardiac arrhythmias, severe ICU-acquired neuromyopathy, chronic obstructive pulmonary disease with forced expiratory volume <50% of the theoretical predicted value, patients with planned prophylactic noninvasive ventilation after extubation, and patients who had previously failed a SBT
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Parasternal Intercostal Muscle Thickness Versus Ultrasound Assessment of Lung Aeration as a Predictor of Weaning From Mechanical Ventilation; a Prospective Observational Study
Examine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU).
- Being tested
- Ultrasound Assessment of the aeration of lung tissue and Parasternal Intercostal Muscle Thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Assessment of the aeration of lung tissue and Parasternal Intercostal Muscle ThicknessDiagnostic test
Examine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU)
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this prospective observational study is to evaluate the predictive value of parasternal intercostal muscle thickness vs ultrasound assessment of lung aeration for prediction of weaning outcome from mechanical ventilation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud hafez, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685224
- Sponsor's protocol ID
- Prediction of Weaning Outcome
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.
PubMed 32894372Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
PubMed 25501898Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
PubMed 19633538Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
PubMed 9927366Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
PubMed 27030815Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.
PubMed 21616997Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasternal Intercostal Muscle Thickness Versus Ultrasound Assessment of Lung Aeration as a Predictor of Weaning From Mechanical Ventilation; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06685224
- Acronym / sponsor ID
- Prediction of Weaning Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Nov 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.
Examine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tanta University Hospitals
Key inclusion criteria (1 listed)
- Mechanically ventilated patients will be included in the study when the underlying disease that had required intubation is considered by the attending physician as reversed and after fulfilling the criteria of weaning (alertness, and Adequate gas exchange, normal pH levels, low and stable doses of vasoactive drugs, normal electrolyte levels, and a rapid shallow breathing index (RSBI) of 105 breaths per minute per liter or lower ) rendering the patient eligible to a first SBT.
Key exclusion criteria (1 listed)
- Exclusion criteria include patients aged < 21yrs , patients with tracheostomy, paraplegia with medullar level above T8, cardiac arrhythmias, severe ICU-acquired neuromyopathy, chronic obstructive pulmonary disease with forced expiratory volume <50% of the theoretical predicted value, patients with planned prophylactic noninvasive ventilation after extubation, and patients who had previously failed a SBT
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 |
|---|---|---|
| Ultrasound Assessment of the aeration of lung tissue and Parasternal Intercostal Muscle ThicknessExamine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU) | Diagnostic test | – |
Primary outcome
The aim of this prospective observational study is to evaluate the predictive value of parasternal intercostal muscle thickness vs ultrasound assessment of lung aeration for prediction of weaning outcome from mechanical ventilation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 32894372Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.
- Results publication: PubMed 25501898Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
- Results publication: PubMed 19633538Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
- Results publication: PubMed 9927366Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
- Results publication: PubMed 27030815Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
- Results publication: PubMed 21616997Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.
- Results publication: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients, run by Tanta 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Farouk Abdelkader Mostafa, Professor (201270440771, shaimaafarouk@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this prospective observational study is to evaluate the predictive value of parasternal intercostal muscle thickness vs ultrasound assessment of lung aeration for prediction of weaning outcome from mechanical ventilation (time frame: 6 months). 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 NCT06685224, which also lists 7 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 27 Jan 2025.