NCT06971042

Brief Summary

The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest .

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 6, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Acute respiratory distress syndrome

    Accuracy of lung ultrasound score in diagnosis of Acute respiratory distress syndrome in comparison with Lung computed tomography .

    Within 48 hours

Secondary Outcomes (1)

  • Severity of Acute respiratory distress syndrome .

    Within 48 hours

Interventions

Patients were examined in supine position, using a portable ultrasound machine equipped with a curvilinear transducer (5-3 MHz)

Also known as: Lung computed tomography

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted in surgical Intensive care unit that mechanically ventilated more than 24 hours who fulfill criteria of Acute Respiratory Distress Syndrome according to Berlin definition.

You may qualify if:

  • Patients aged more than 21 years old of both sexes .
  • Patients who are expected to be mechanically ventilated more than 24 h .
  • Patients who are suspected to be Acute Respiratory Distress Syndrome according to Berlin definition which consists of clinical criteria and with precipitating factors which starts within 1 week of known insult as in trauma patients with lung contusions.

You may not qualify if:

  • History of pre-existing lung disease ( tumors, interstitial lung diseases)
  • In cases of volume overload.
  • Patients with acute kidney injuiry or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Roaa Elshamy, MSc

    Tanta University

    PRINCIPAL INVESTIGATOR
  • Roaa Elshamy

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roaa Elshamy, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

August 10, 2024

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations