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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05763134
Other study ID # ultrasound weaning
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date July 20, 2023

Study information

Verified date February 2023
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The aim of this study is to reduce the number of extubation failures by defining the etiology of weaning failure and developing appropriate treatment strategies by using intensive care ultrasonography applications in combination (defining cardiac, pulmonary, diaphragmatic and venous congestion). Most patients can be extubated after the first SBT (spontaneous Breathing Trial). A patient who fails extubation is automatically classified as difficult weaning, and intensive care professionals frequently encounter patients who are difficult to wean from mechanical ventilation. Before performing a new SBT following a failed SBT, the cause of the failure should be determined and an appropriate treatment strategy developed.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date July 20, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Invasive mechanical ventilation > 24 hours Eligibility to weaning from mechanical ventilation Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Antalya Training and Research Hospital Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanical ventilation weaning success Weaning success: stable without mechanical ventilator support during more than 48 hours 48 hours
Primary Mechanical ventilation weaning failure Weaning failure: unstable without mechanical ventilator support within 48 hours 48 hours
Secondary Mortality Incidence of ICU mortality ICU mortality after ultrasonography guided weaning
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