- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030401
Role Of Transthoracic Ultrasound in Predicting Post-extubation Distress During Successful Weaning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of post-extubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation or a trial of totally unsupported respiration are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU.
The Investigators hypothesized that the use of an integrative thoracic ultrasound assessment, encompassing bedside respiratory, and diaphragm sonographic data, could accurately predict post-extubation distress in patients who succeeded in a pressure support ventilation trial. In addition, The Investigators suggest that the use of appropriate analytical methods, that is, machine-learning methods, could permit the evaluation of the specific impact of respiratory and diaphragm sonographic data on the final estimation of a likelihood of post-extubation distress .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rehab Haredy Hassan, Resident Physicion
- Phone Number: 01026128677
- Email: rehabharedy@gmail.com
Study Contact Backup
- Name: Maha kamel Ghanem, prof
- Phone Number: 01227694434
- Email: mahaghanem@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients above 18 yrs. old who admitted to respiratory ICU and mechanically ventilated due to chest diseases and passed weaning trials
Exclusion Criteria:
- Pregnancy.
- Neuromuscular disorders.
- Psychiatric instability.
- Uncontrolled cardiovascular disease.
- Tracheostomy.
- patints with failed weaning trials.
- Inability to provide informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-extubation distress
Time Frame: "through study completion, an average of 3 year".
|
Using Transthoracic US to measure Diaphragmatic Excursion and Diaphragmatic Thickness as Predictors of Postextubation Distress during Successful Weaning Trials.
|
"through study completion, an average of 3 year".
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of different factors that affect weaning outcome as diaphragmatic dysfunction,ventilator associated pneumonia,electrolyte disturbances and so on.
Time Frame: Doing Transthoracic US 48 hour after Starting of Mechanical Ventilation when Patient becomes Weanable during Weaning Trials,and 48 hour Postextubation Weaning and 48 hour postextubation.
|
Looking on Diaphragmatic function And If There is any Ventilator Associated pneumonia And Electrolyte Disturbance
|
Doing Transthoracic US 48 hour after Starting of Mechanical Ventilation when Patient becomes Weanable during Weaning Trials,and 48 hour Postextubation Weaning and 48 hour postextubation.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hoda Ahmad Ali, prof, Respiratory ICU of Assiut University Hospital
- Study Director: Ali Abdelazeem Hassan, prof, Respiratory ICU of Assiut University Hospital
Publications and helpful links
General Publications
- Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
- Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
- Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguia C, Gonzalez M, Hill NS, Nava S, D'Empaire G, Anzueto A. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. doi: 10.1378/chest.130.6.1664.
- Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
- Lichtenstein DA. Point-of-care ultrasound: Infection control in the intensive care unit. Crit Care Med. 2007 May;35(5 Suppl):S262-7. doi: 10.1097/01.CCM.0000260675.45549.12.
- McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2013 Mar 14;368(11):1068-9. doi: 10.1056/NEJMc1300398. No abstract available.
- Epstein SK, Nevins ML, Chung J. Effect of unplanned extubation on outcome of mechanical ventilation. Am J Respir Crit Care Med. 2000 Jun;161(6):1912-6. doi: 10.1164/ajrccm.161.6.9908068.
- Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC. Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8. doi: 10.1378/chest.123.4.1222.
- Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Transthoracic US
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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