NCT06030401

Brief Summary

-To Assess Value of Transthoracic Ultrasound In Predicting Post-extubation Distress in Respiratory ICU Using Ultrasound Parameters As Diaphragmatic Excursion ,Diaphragmatic,Diaphragmatic Thickness Fraction,Diaphragmatic Thickness.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Status
unknown

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

August 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

August 9, 2023

Last Update Submit

September 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-extubation distress

    Using Transthoracic US to measure Diaphragmatic Excursion and Diaphragmatic Thickness as Predictors of Postextubation Distress during Successful Weaning Trials.

    "through study completion, an average of 3 year".

Secondary Outcomes (1)

  • Evaluation of different factors that affect weaning outcome as diaphragmatic dysfunction,ventilator associated pneumonia,electrolyte disturbances and so on.

    Doing Transthoracic US 48 hour after Starting of Mechanical Ventilation when Patient becomes Weanable during Weaning Trials,and 48 hour Postextubation Weaning and 48 hour postextubation.

Interventions

Sonar of The Chest

Eligibility Criteria

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

.Any Patient Has Successful Weaning Trial above18Years old in Respiratory ICU

You may qualify if:

  • Patients above 18 yrs. old who admitted to respiratory ICU and mechanically ventilated due to chest diseases and passed weaning trials

You may not qualify if:

  • Pregnancy.
  • Neuromuscular disorders.
  • Psychiatric instability.
  • Uncontrolled cardiovascular disease.
  • Tracheostomy.
  • patints with failed weaning trials.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguia C, Gonzalez M, Hill NS, Nava S, D'Empaire G, Anzueto A. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. doi: 10.1378/chest.130.6.1664.

    PMID: 17166980BACKGROUND
  • Lichtenstein DA. Point-of-care ultrasound: Infection control in the intensive care unit. Crit Care Med. 2007 May;35(5 Suppl):S262-7. doi: 10.1097/01.CCM.0000260675.45549.12.

  • Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  • Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  • Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.

  • McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2013 Mar 14;368(11):1068-9. doi: 10.1056/NEJMc1300398. No abstract available.

  • Epstein SK, Nevins ML, Chung J. Effect of unplanned extubation on outcome of mechanical ventilation. Am J Respir Crit Care Med. 2000 Jun;161(6):1912-6. doi: 10.1164/ajrccm.161.6.9908068.

  • Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC. Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8. doi: 10.1378/chest.123.4.1222.

  • Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.

Study Officials

  • Hoda Ahmad Ali, prof

    Respiratory ICU of Assiut University Hospital

    STUDY DIRECTOR
  • Ali Abdelazeem Hassan, prof

    Respiratory ICU of Assiut University Hospital

    STUDY DIRECTOR

Central Study Contacts

Rehab Haredy Hassan, Resident Physicion

CONTACT

Maha kamel Ghanem, prof

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 9, 2023

First Posted

September 11, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09