Prediction of Weaning Outcome from Mechanical Ventilation Using Ultrasound

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients
• Intervention / Treatment: Diagnostic test: Ultrasound Assessment of the aeration of lung tissue and Parasternal Intercostal Muscle Thickness

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mahmoud Tarek Hafez; Phone Number: 201221852681; Email: mth1346686@gmail.com
• Study Contact Backup: Name: Shaimaa Farouk Abdelkader Mostafa, Professor; Phone Number: 201270440771; Email: shaimaafarouk@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Tanta University Hospitals

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Boles 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.
• Penuelas 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.
• Esteban 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.
• Bouhemad 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.
• Bouhemad 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.
• Berger 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: Prediction of Weaning Outcome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No