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

Sponsor

JinyanXing (Other)

Overall Status

Recruiting

CT.gov ID

NCT05035355

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiration, Artificial	Procedure: a weaning protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: weaning protocol group spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula group	Procedure: a weaning protocol a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)
No Intervention: routine SBT weaning group

Arm

Intervention/Treatment

Experimental: weaning protocol group

spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula group

Procedure: a weaning protocol

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

No Intervention: routine SBT weaning group

Outcome Measures

Primary Outcome Measures

mechanical ventilation days [60 days]
the duration of mechanical ventilation

Secondary Outcome Measures

re-intubated within 24 hours [24 hours]
re-intubated within 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266555

Sponsors and Collaborators

JinyanXing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JinyanXing, Director, The Affiliated Hospital of Qingdao University

ClinicalTrials.gov Identifier:

NCT05035355

Other Study ID Numbers:

QYFYWZLL26347

First Posted:

Sep 5, 2021

Last Update Posted:

Sep 10, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by JinyanXing, Director, The Affiliated Hospital of Qingdao University

Protocol-directed weaning

Mechanical ventilation

High-flow nasal cannula

Spontaneous breathing trial

Study Results

No Results Posted as of Sep 10, 2021