Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion

NCT07143695 | Recruiting

• 1 other identifier: PIC criterion
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill

Keywords

Weaning; re-intubation; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Incidence of reintubation

  need for reintubation

  Within 72 hours after extubation

Secondary Outcomes (1)

• Incidence of weaning failure

  within 72 hours post-extubation

Study Arms (2)

Control group

SHAM COMPARATOR

patients in control will be weaning using standard criteria

Device: Sham parasternal intercostal thickening

Ultrasound

ACTIVE COMPARATOR

patient in this group will be weaned using standard criteria plus mean parasternal thickening fraction less than 6.5 %

Device: Parasternal intercostal thickening fraction

Interventions

Parasternal intercostal thickening fraction DEVICE

Parasternal intercostal thickening fraction less than 6.5%

Ultrasound

Sham parasternal intercostal thickening DEVICE

Ultrasound assessment only for purpose of blinding

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patient refusal difficult ultrasound views tracheostomized patient neuromuscular disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 35487407 BACKGROUND

• 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.

  PMID: 36961635 BACKGROUND

• 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.

  PMID: 39174907 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cairo university

CONTACT

+201275716942; kasralainirec@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and critical care

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

EG (1)