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

September 3, 2021 updated by: JinyanXing

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinyan Xing, Doctor
  • Phone Number: 82919386 86-0532-82919386
  • Email: xingjy@qdu.edu.cn

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266555
        • Recruiting
        • The affiliated hospital of Qingdao university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mechanical ventilation days
Time Frame: 60 days
the duration of mechanical ventilation
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
re-intubated within 24 hours
Time Frame: 24 hours
re-intubated within 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JinyanXing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QYFYWZLL26347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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