Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning

Mechanical Ventilation Clinical Trial

Official title:

Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03574233
• Other study ID #: 4-2018-0357
• Status: Recruiting
• Start date: March 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: Kyungsoo Chung, MD
• Phone: 82-2-2228-2270
• Email: CHUNGKS[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators aimed to develop integrated ultrasound guided mechanical weaning protocol in critically ill patients. The analysis will be taken (1) just before the spontaneous breathing trial in enrolled patients with mechanical ventilation and (2) in patients with tracheostomy who fail ventilator off.

Description:

Prolonged mechanical ventilation is associated with higher ventilator-associated pneumonia and ventilator-associated lung injury, longer intensive care unit and hospital days, increased mortality, and higher medical costs. However, some patients are difficult to wean from invasive mechanical ventilation. Typically, the difficulty in transitioning patients to spontaneous breathing may be categorized as simple transition, difficult transition, and prolonged transition.

There are a lot of predictors for weaning failure such as cardiac dysfunction, increased respiratory rate, diaphragm dysfunction, rapid shallow breathing index and so on. However, weaning failure involves complicated mechanisms that are not solved by one cause. Recently, P. Mayo published a review paper on ultrasonography evaluation during the weaning process. The investigators need to pay attention to this paper. While lots of previous predictors cannot explain the reason, ultrasound evaluation is a process of finding the cause as well as prediction for weaning failure. However, The investigators need a more practical and standardized ultrasound protocols for how to wean invasive mechanical ventilation. "Ultrasonographic mechanical weaning protocol" should not comprise just one indicator, but include various indicators such as upper airway stenosis, heart function, the status of the lung and pleura, diaphragmatic function, Etc. This integrated ultrasound protocol will help in successful weaning of invasive mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Invasive mechanical ventilation > 24 hours

2. Eligibility to weaning from mechanical ventilation

Exclusion Criteria:

1. Age < 18 years old

2. Severe skin lesions or infections that cannot perform ultrasound

3. Severe subcutaneous emphysema that cannot perform ultrasound

4. Patients who completed "Do-not-resuscitation" consents

Related Conditions & MeSH terms

• Mechanical Ventilation

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of ultrasound indices associated with the success or failure of mechanical ventilation weaning	Weaning success: stable without mechanical ventilator support during more than 48 hours; Weaning failure: unstable without mechanical ventilator support within 48 hours A) Type I respiratory failure: high flow oxygen support B) Type II respiratory failure: non-invasive ventilatory support C) Reintubation	within 48 hours
Secondary	A) In-ICU mortality		90 days after Ultrasonography
Secondary	B) In-hospital mortality		90 days after Ultrasonography
Secondary	C) Ventilator free day		90 days after Ultrasonography
Secondary	D) ICU free day		90 days after Ultrasonography