NCT01535755

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

February 11, 2012

Last Update Submit

July 15, 2013

Conditions

Keywords

noninvasive mechanical ventilationventilator weaning

Outcome Measures

Primary Outcomes (1)

  • The duration of noninvasive mechanical ventilation

    The duration of noninvasive mechanical ventilation was measured from the patients admitted to ICU to discharged from it,an expected average of 4 weeks.

    from admission to ICU to discharge from it (average of 4 weeks)

Secondary Outcomes (4)

  • 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)

Study Arms (2)

protocol group

ACTIVE COMPARATOR

This group patients are weaned as the protocol which the investigators described.

Device: protocol

clinicians' order group

OTHER

This group patients are weaned as the clinicians' order.

Other: physician's orders

Interventions

protocolDEVICE

In this group, the patients were weaned as the protocol.

Also known as: In this group, the patients were weaned as the protocol.
protocol group

In this group, the patients were weaned as the clinicians' order.

Also known as: In this group, the patients were weaned as the clinicians' order.
clinicians' order group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiated hospital, chongqing medical university

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Jun Duan

    The first affiliated hospital, Chongqing medical hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The first affiliated hospital of chong qing medical univercity

Study Record Dates

First Submitted

February 11, 2012

First Posted

February 20, 2012

Study Start

July 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations