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NCT05035355 Clinical Trial

A SBT-based Protocol-directed Program in Difficult-to-Wean Patients

Respiration, Artificial Clinical Trial

Official title:
A Spontaneous Breathing Trial-based Protocol-directed Program in Difficult-to-Wean Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05035355
Other study ID # QYFYWZLL26347
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information
Verified date September 2021
Source The Affiliated Hospital of Qingdao University
Contact Jinyan Xing, Doctor
Phone 86-0532-82919386
Email xingjy@qdu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria: - age = 16 years old - MV for more than 48 hours - intubated or tracheostomized Exclusion Criteria: - pregnancy - irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy - pre-existing decision to limit life support - waiving of MV during treatment - terminal stage of severe illness

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• a weaning protocol
a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)

Locations
Country Name City State
China The Affiliated Hospital of Qingdao University Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
JinyanXing

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mechanical ventilation days the duration of mechanical ventilation 60 days
Secondary re-intubated within 24 hours re-intubated within 24 hours 24 hours
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