NCT06465082

Brief Summary

The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

June 13, 2024

Last Update Submit

May 27, 2025

Conditions

Weaning From Mechanical Ventilation

Keywords

mechanical ventilation.diaphragmatic thickening Fraction

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation.

    assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

    Baseline and after 6 month

Eligibility Criteria

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

Adult patients \>18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate \> 30 breath/min, Disturbed conscious level.

You may qualify if:

  • Adult patients \>18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate \> 30 breath/min, Disturbed conscious level.

You may not qualify if:

  • Age \<18 years.
  • Pregnancy
  • Surgical incisions likely to interfere with ultrasound examination.
  • Hepato-splenomegaly, Ascites
  • Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
  • Diaphragmatic Paralysis (paralyzed diaphragm exhibiting abnormal paradoxical movement, i.e., moving in a cranial direction during inspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

RECRUITING

Study Officials

  • Mohamed AbdElmoniem

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AbdElmoniem

CONTACT

01014008473dr.m1993@mans.edu.eg

Taha Taha Abd El Gawad

CONTACT

01014008473

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest medicine

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

September 5, 2024

Primary Completion

July 15, 2025

Study Completion

December 15, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

EG(1)