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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01535755
Other study ID # cqykdxfsdyyy2
Secondary ID
Status Terminated
Phase N/A
First received February 11, 2012
Last updated July 15, 2013
Start date July 2010
Est. completion date May 2011

Study information

Verified date July 2013
Source Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 80
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Device:
protocol
In this group, the patients were weaned as the protocol.
Other:
physician's orders
In this group, the patients were weaned as the clinicians' order.

Locations

Country Name City State
China The first affiated hospital, chongqing medical university ChongQing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Duan jun

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Yes
Secondary The successful weaning rate The successful weaning rate 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) Yes
Secondary The length of ICU days The length of ICU days 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) Yes
Secondary The intubation rate during the study The intubation rate during the study 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) Yes
Secondary The mortality during the study The mortality during the study 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) Yes
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