Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients

September 29, 2016 updated by: Duan jun, Chongqing Medical University

Efficacy and Safety of Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients: a Randomized Control Trial

The aim of this study is to facilitate weaning by switching between invasive and noninvasive ventilation in difficult-weaning patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study only enrolled patients with tracheotomy. When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.A patient in intervention group is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Study Type

Interventional

Enrollment (Anticipated)

160

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: Guosheng Ren, MD
  • Phone Number: 02389012680

Study Locations

  • China
    • Chongqing
      • ChongQing, Chongqing, China, 400016
        • Recruiting
        • The first affiated hospital, chongqing medical 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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • duration of invasive ventilation ≥14 days
  • anticipation of difficult weaning
  • Glasgow Coma Scale ≥13
  • no upper airway obstruction
  • presence of spontaneous breath

Exclusion Criteria:

  • age less than 18 or more than 85 years
  • contraindications for noninvasive ventilation
  • anticipation of survival less than 6 months
  • refusal of tracheotomy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients in this group are weaned from ventilator as conventional methods.
Experimental: Intervention group
Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation
Procedure: switching between invasive and noninvasive ventilation
As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ventilator weaning days
Time Frame: from enrollment to 90 days
from enrollment to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
successful weaning rate
Time Frame: from enrollment to 90 days
from enrollment to 90 days
ICU stay days
Time Frame: from admission to 90 days
from admission to 90 days
hospital stay days
Time Frame: from admission to 90 days
from admission to 90 days
ICU mortality
Time Frame: from admission to 90 days
from admission to 90 days
hospital mortality
Time Frame: from admission to 90 days
from admission to 90 days

Collaborators and Investigators

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

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Shuliang Guo, MD, First Affiliated Hospital of Chongqing Medical University

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

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • cqykdxfsdyyy4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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