NCT07083128

Brief Summary

optimal time to liberate from mechanical ventilation is highly prioritized since improper extubation time lead to serious consequences

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

July 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

July 5, 2025

Last Update Submit

March 21, 2026

Conditions

Keywords

Parasternal thickening; failed weaning; extubation

Outcome Measures

Primary Outcomes (1)

  • Accuracy of change in PIC-TF in predicting successful weaning from mechanical ventilation

    percentage of change in PIC TF in predicting weaning outcome (PIC TF30-PIC TF0)

    At baseline and 30 minutes after initiation of spontaneous breathing trial

Secondary Outcomes (1)

  • Accuracy of change in PIC-TF to predict reintubation

    At baseline and 30 minutes after initiation of spontaneous breathing trial

Interventions

Temporal change in parasternal intercostal thickening fraction at initiation and 30 minutes of spontaneous breathing trial

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient who are mechanically ventilated for 24 hours or more and ready for weaning

You may qualify if:

  • \- Mechanically ventilated for 24 hours or more ready for weaning

You may not qualify if:

  • Refusal Tracheostomized Inability to obtain ultrasound views patients with neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

Location

Related Publications (5)

  • 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.

  • Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.

  • Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 24, 2025

Study Start

July 13, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations