NCT06078254

Brief Summary

The aim of this study is to evaluate the accuracy, sensitivity and specificity of lung ultrasound in early detection of ARDS and Pneumonia in comparison to CT chest in patients with chest trauma. Also, we aim at finding any pulmonary complications and its correlation to development of ARDS and pneumonia in patients with chest trauma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

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

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

October 5, 2023

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma.

    Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma.

    18 MONTHS

Secondary Outcomes (1)

  • Correlation between occurrence of different pulmonary complications due to chest trauma and development of ARDS and pneumonia in patients with chest trauma.

    18 MONTHS

Interventions

Ultrasound and CT chest for all patients

Also known as: COMPUTERIZED TOMOGRAPHY

Eligibility Criteria

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

Patients who admitted to critical area with chest trauma will perform both CT chest and lung ultrasound and will be followed up by ultrasound to detect any pulmonary complication and early detection of ARDS and pneumonia.

You may qualify if:

  • All ICU patients who got admitted to critical care department with chest trauma.

You may not qualify if:

  • Pediatric patients aged less than 18 years old.
  • Any patients have previous lung disease like (IPF, lung cancer, respiratory failure and pulmonary hypertension).
  • Pregnant females at any gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University

Cairo, Cairo Governorate, 11231, Egypt

RECRUITING

Related Publications (8)

  • Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.

    PMID: 32417043BACKGROUND
  • Ferrer M, Difrancesco LF, Liapikou A, Rinaudo M, Carbonara M, Li Bassi G, Gabarrus A, Torres A. Polymicrobial intensive care unit-acquired pneumonia: prevalence, microbiology and outcome. Crit Care. 2015 Dec 23;19:450. doi: 10.1186/s13054-015-1165-5.

    PMID: 26703094BACKGROUND
  • Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, Panebianco V, Andreoli C, Colaiacomo MC, Zingaropoli MA, Ciardi MR, Mastroianni CM, Pugliese F, Alessandri F, Turriziani O, Ricci P, Catalano C. Chest CT score in COVID-19 patients: correlation with disease severity and short-term prognosis. Eur Radiol. 2020 Dec;30(12):6808-6817. doi: 10.1007/s00330-020-07033-y. Epub 2020 Jul 4.

    PMID: 32623505BACKGROUND
  • Mardani P, Moayedi Rad M, Paydar S, Amirian A, Shahriarirad R, Erfani A, Ranjbar K. Evaluation of Lung Contusion, Associated Injuries, and Outcome in a Major Trauma Center in Shiraz, Southern Iran. Emerg Med Int. 2021 Apr 22;2021:3789132. doi: 10.1155/2021/3789132. eCollection 2021.

    PMID: 33976939BACKGROUND
  • Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.

    PMID: 32053470BACKGROUND
  • Soni NJ, Franco R, Velez MI, Schnobrich D, Dancel R, Restrepo MI, Mayo PH. Ultrasound in the diagnosis and management of pleural effusions. J Hosp Med. 2015 Dec;10(12):811-6. doi: 10.1002/jhm.2434. Epub 2015 Jul 28.

    PMID: 26218493BACKGROUND
  • Raghavendran K, Notter RH, Davidson BA, Helinski JD, Kunkel SL, Knight PR. Lung contusion: inflammatory mechanisms and interaction with other injuries. Shock. 2009 Aug;32(2):122-30. doi: 10.1097/SHK.0b013e31819c385c.

    PMID: 19174738BACKGROUND
  • Hyllienmark P, Brattstrom O, Larsson E, Martling CR, Petersson J, Oldner A. High incidence of post-injury pneumonia in intensive care-treated trauma patients. Acta Anaesthesiol Scand. 2013 Aug;57(7):848-54. doi: 10.1111/aas.12111. Epub 2013 Mar 31.

    PMID: 23550742BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Interventions

UltrasonographyTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage Interpretation, Computer-AssistedRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Omar M. Taha Elsafty, professor

    Ain Shams University

    STUDY CHAIR
  • Kareem Y. Kamal Hakim, professor

    Ain Shams University

    STUDY DIRECTOR
  • Amr G. Sharaf, MD

    Ain Shams University

    STUDY DIRECTOR
  • Eman M. Hesham Elshaer, MD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

October 30, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations