NCT07630662

Brief Summary

Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis. The ultrasound estimation of parasternal intercostal muscle and diaphragmatic functions is a method to evaluate if there is a good chance of weaning outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ultrasound guided muscles function assessment

    \- Evaluation of the efficacy of diaphragmatic and parasternal intercostal muscle functions as a predictors of successful weaning from mechanical ventilation.

    30-60 minutes

Study Arms (1)

diaphragmatic and parasternal muscles function assessment

Patients who fulfilling the initial parameters for possibility of weaning will undergo spontaneous breathing trial (SBT) for 30 minutes. All patients will be positioned in a semi sitting position at approximately 30 degree, and will be monitored closely during SBT period. Ultrasound assessment for the parasternal intercostal and diaphragmatic muscle functions will be done at the end of SBTs for all patients. Ultrasound assessment of diaphragm: Diaphragmatic excursion; The diaphragmatic movement will be measured using a 3.5-MHz ultrasound probe. With the probe fixed on the chest wall during respiration, the patient will be asked to take a maximum breath. The right hemi-diaphragm will be measured by positioning the probe between the mid-clavicular and mid-axillary lines below the right costal margin (subcostal approach) using the liver as acoustic window. The probe will be positioned medially, cephalic and dorsally. Till the hemi-diaphragm will be well visualized. The M-mood will be ap

Eligibility Criteria

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

intubated ventilated patients in ICU for more than 48 h

You may qualify if:

  • \. Adult patients more than 18 years old. 2. Patient on mechanical ventilation more than 48 hours.

You may not qualify if:

  • \. Declining to give a written informed consent. 2. Diaphragmatic paralysis or injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

RECRUITING

Central Study Contacts

Mohamed I Ezz eldein

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 5, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations