NCT05763134

Brief Summary

Weaning patients from the ventilator in the intensive care unit is sometimes difficult because of three main interrelated etiologies: impaired lung, heart or diaphragm function. In this context, ultrasonography performed during tests for extubation of patients may enable the diagnosis of cardiac dysfunction, loss of pulmonary aeration, diaphragm dysfunction, and venous congestion, thereby reducing the number of failures in extubation. The combination of TTE (Trans Thoracic Echocardiography), LUS (Lung Ultrasound), DUS (Diaphragmatic ultrasound) and VEXUS (Venous excess Ultrasound) may enable the identification of the etiology of weaning failure and reduce the number of extubation failures by enabling the development of an appropriate treatment strategy. With this study, it is aimed to contribute to the literature in this sense.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

July 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 28, 2023

Last Update Submit

July 20, 2023

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (2)

  • Mechanical ventilation weaning success

    Weaning success: stable without mechanical ventilator support during more than 48 hours

    48 hours

  • Mechanical ventilation weaning failure

    Weaning failure: unstable without mechanical ventilator support within 48 hours

    48 hours

Secondary Outcomes (1)

  • Mortality

    ICU mortality after ultrasonography guided weaning

Study Arms (2)

weaning failure

Unstable patient without mechanical ventilator support within 48 hours

weaning success

Stable patient for more than 48 hours without mechanical ventilator support

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The researchers aimed to predict the success and failure of extubation and measure the associated ultrasound indices with the combined ultrasound-guided weaning protocol in all critically ill patients over the age of 18 who remain on mechanical ventilator for more than 24 hours and are thought to be ready for weaning. Evaluations will be made just before the spontaneous breathing trial and at the end of the spontaneous breathing trial in critically ill patients undergoing mechanical ventilation.

You may qualify if:

  • Invasive mechanical ventilation \> 24 hours Eligibility to weaning from mechanical ventilation

You may not qualify if:

  • Age \< 18 years old
  • Severe skin lesions or infections that cannot perform ultrasound
  • Severe subcutaneous emphysema that cannot perform ultrasound
  • Patients with a known neuromuscular disease
  • Patients with a duration of mechanical ventilation \<24 hours,
  • Patients with severe mitral stenosis, severe mitral regurgitation, or prosthetic mitral valve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, 07059, Turkey (Türkiye)

Location

Related Publications (2)

  • Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

    PMID: 17470624BACKGROUND

  • Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.

    PMID: 28917004BACKGROUND

Study Officials

  • Şule Asrı

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

March 1, 2023

Primary Completion

June 30, 2023

Study Completion

July 20, 2023

Last Updated

July 21, 2023

Record last verified: 2023-02

Locations

TU(1)