A Protocol to Wean From Noninvasive Mechanical Ventilation

This study has been terminated.
(Enough patients has been enrolled.)
Sponsor:
Information provided by (Responsible Party):
Duan jun, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01535755
First received: February 11, 2012
Last updated: July 15, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Protocol to Wean From Noninvasive Mechanical Ventilation

Further study details as provided by 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 11, 2012
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014