Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion

Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion to Minimize Re-intubation Rate: a Randomized Controlled Trial

Increased days of MV are not without hazards, including barotraumas and ventilator-associated pneumonia. Similarly, premature separation of MV is associated with increased mortality secondary to adverse cardiorespiratory events. Therefore, the time of weaning should be wisely evaluated. There is growing evidence concerning respiratory muscles dysfunction that contributes to difficulty or prolonged liberation from MV.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill
• Intervention / Treatment: Device: Sham parasternal intercostal thickening; Device: Parasternal intercostal thickening fraction

Detailed Description

Researchers aim to evaluate the influence of adding parasternal thickening fraction to the standard weaning criteria and its impact on reintubation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cairo University; Phone Number: +201275716942; Email: kasralainirec@gmail.com

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt, 6890
      • Recruiting
      • Cairo University
      • Contact: Mina Helmy; Phone Number: 01275716942; Email: dr_mina20002010@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• critically ill patient mechanically ventilated for 24 hours or more first spontaneous breathing trial

Exclusion Criteria:

• patient refusal difficult ultrasound views tracheostomized patient neuromuscular disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; patients in control will be weaning using standard criteria	Device: Sham parasternal intercostal thickening; Ultrasound assessment only for purpose of blinding
Active Comparator: Ultrasound; patient in this group will be weaned using standard criteria plus mean parasternal thickening fraction less than 6.5 %	Device: Parasternal intercostal thickening fraction; Parasternal intercostal thickening fraction less than 6.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reintubation	need for reintubation	Within 72 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of weaning failure	failed spontaneous breathing trial or reintubation	within 72 hours post-extubation

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Helmy MA, Hasanin A, Milad LM, Mostafa M, Hamimy WI, Muhareb RS, Raafat H. Ability of parasternal intercostal muscle thickening fraction to predict reintubation in surgical patients with sepsis. BMC Anesthesiol. 2024 Aug 22;24(1):294. doi: 10.1186/s12871-024-02666-8.
• Helmy MA, Milad LM, Hasanin AM, Mostafa M, Mannaa AH, Youssef MM, Abdelaziz M, Alkonaiesy R, Elshal MM, Hosny O. Parasternal intercostal thickening at hospital admission: a promising indicator for mechanical ventilation risk in subjects with severe COVID-19. J Clin Monit Comput. 2023 Oct;37(5):1287-1293. doi: 10.1007/s10877-023-00989-4. Epub 2023 Mar 24.
• Helmy MA, Hasanin A, Milad LM, Mostafa M, Fathy S. Parasternal intercostal muscle thickening as a predictor of non-invasive ventilation failure in patients with COVID-19. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101063. doi: 10.1016/j.accpm.2022.101063. Epub 2022 Apr 26. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Estimated): August 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; Weaning; re-intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: PIC criterion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD might not be shared to protect confidentiality, maintain competitive advantage, and comply with legal or contractual restrictions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No