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A Protocol to Wean From Noninvasive Mechanical Ventilation

This study has been terminated.
(Enough patients has been enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535755
First Posted: February 20, 2012
Last Update Posted: July 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duan jun, Chongqing Medical University
  Purpose
The investigators use a protocol to wean from noninvasive mechanical ventilation.

Condition Intervention
Ventilator Weaning Device: protocol Other: physician's orders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Protocol to Wean From Noninvasive Mechanical Ventilation

Further study details as provided by Duan jun, Chongqing Medical University:

Primary Outcome Measures:
  • The duration of noninvasive mechanical ventilation [ Time Frame: from admission to ICU to discharge from it (average of 4 weeks) ]
    The duration of noninvasive mechanical ventilation was measured from the patients admitted to ICU to discharged from it,an expected average of 4 weeks.


Secondary Outcome Measures:
  • The successful weaning rate [ Time Frame: from admission to ICU to discharge from it (average of 4 weeks) ]
    The successful weaning rate was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.

  • The length of ICU days [ Time Frame: from admission to ICU to discharge from it (average of 4 weeks) ]
    The length of ICU days was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.

  • The intubation rate during the study [ Time Frame: from admission to ICU to discharge from it (average of 4 weeks) ]
    The intubation rate during the study was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.

  • The mortality during the study [ Time Frame: from admission to ICU to discharge from it (average of 4 weeks) ]
    The mortality during the study was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.


Enrollment: 80
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: protocol group
This group patients are weaned as the protocol which the investigators described.
Device: protocol
In this group, the patients were weaned as the protocol.
Other Name: In this group, the patients were weaned as the protocol.
clinicians' order group
This group patients are weaned as the clinicians' order.
Other: physician's orders
In this group, the patients were weaned as the clinicians' order.
Other Name: In this group, the patients were weaned as the clinicians' order.

Detailed Description:
Design: Prospective, randomized, controlled trial, with 2 groups: study (protocol weaning group) and control (clinicians' order weaning group). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients >18 yr, noninvasive mechanical ventilation >24 hours. Interventions and measurements: Study group (weaning as the protocol) and control group (weaning as the clinicians' order); recording of clinical variables at admission and during RICU stay, and end-point variables (noninvasive mechanical ventilation day, RICU and hospital stay, RICU mortality. Expected results: the protocol group's noninvasive mechanical ventilation days is less than clinicians' order group.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. noninvasive mechanical ventilation > 24 hours.
  2. age >18 years

Exclusion Criteria:

  1. severe cerebraI,heart,hepatic and renal faiIure.
  2. facial or cranial trauma or surgery.
  3. facial abnormalities.
  4. recent gastric or esophageal surgery.
  5. active upper gastrointestinal bleeding.
  6. large amount of sputum with weak cough ability
  7. lack of co-operation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535755


Locations
China, Chongqing
The first affiated hospital, chongqing medical university
ChongQing, Chongqing, China, 400016
Sponsors and Collaborators
Duan jun
Investigators
Principal Investigator: Jun Duan The first affiliated hospital, Chongqing medical hospital
  More Information

Responsible Party: Duan jun, The first affiliated hospital of chong qing medical univercity, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01535755     History of Changes
Other Study ID Numbers: cqykdxfsdyyy2
First Submitted: February 11, 2012
First Posted: February 20, 2012
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by Duan jun, Chongqing Medical University:
noninvasive mechanical ventilation
ventilator weaning