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Recruiting NCT07143695

Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion

No phase Interventional Critically Ill

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parasternal intercostal thickening fraction, Sham parasternal intercostal thickening.
Who it may be relevant to
Registry conditions: Critically Ill. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • Device Parasternal intercostal thickening fraction
    Parasternal intercostal thickening fraction less than 6.5%
  • Device Sham parasternal intercostal thickening
    Ultrasound assessment only for purpose of blinding

Primary outcome measures

  • Incidence of reintubation [Time frame: Within 72 hours after extubation]
Secondary outcome measures (1)
  • Incidence of weaning failure [Time frame: within 72 hours post-extubation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07143695 · PIC criterion

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗