Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.

Weaning Failure Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05431036
• Other study ID #: lung US in ICU patient
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Alaa M Taghyan, master
• Phone: 01093093050
• Email: alaataghyan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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) Exclusion Criteria
• 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).

Related Conditions & MeSH terms

• Critical Illness
• Weaning Failure

Intervention

Device:
• transthoracic ultrasonography
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Li 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. — View Citation

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. Review. — View Citation

Soummer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline
Primary	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%	baseline
Primary	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.	baseline
Secondary	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.	baseline