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Clinical Trials/NCT01535755
NCT01535755TerminatedNot Applicable

A Protocol to Wean From Noninvasive Mechanical Ventilation

Duan jun1 site in 1 country80 target enrollmentStarted: July 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
The duration of noninvasive mechanical ventilation

Study Overview

Brief Summary

The investigators use a protocol to wean from noninvasive mechanical ventilation.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • noninvasive mechanical ventilation > 24 hours.
  • age >18 years

Exclusion Criteria

  • severe cerebraI,heart,hepatic and renal faiIure.
  • facial or cranial trauma or surgery.
  • facial abnormalities.
  • recent gastric or esophageal surgery.
  • active upper gastrointestinal bleeding.
  • large amount of sputum with weak cough ability
  • lack of co-operation.

Outcomes

Primary Outcomes

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 Outcomes

  • The successful weaning rate(from admission to ICU to discharge from it (average of 4 weeks))
  • The length of ICU days(from admission to ICU to discharge from it (average of 4 weeks))
  • The intubation rate during the study(from admission to ICU to discharge from it (average of 4 weeks))
  • The mortality during the study(from admission to ICU to discharge from it (average of 4 weeks))

Investigators

Sponsor
Duan jun
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Duan jun

The first affiliated hospital of chong qing medical univercity

Chongqing Medical University

Study Sites (1)

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