A Protocol to Wean From Noninvasive Mechanical Ventilation

Not Applicable

Terminated

• Conditions: Ventilator Weaning
• Interventions: Device: protocol; Other: physician's orders

• Registration Number: NCT01535755
• Lead Sponsor: Duan jun

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2012-02-11
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protocol group	protocol	This group patients are weaned as the protocol which the investigators described.
clinicians' order group	physician's orders	This group patients are weaned as the clinicians' order.

Primary Outcome Measures

Name	Time	Method
The duration of noninvasive mechanical ventilation	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

Name	Time	Method
The successful weaning rate	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	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	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	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.

Trial Locations

Locations (1)

The first affiated hospital, chongqing medical university; 🇨🇳 ChongQing, Chongqing, China