A Protocol to Wean From Noninvasive Mechanical Ventilation

Ventilator Weaning Clinical Trial

Official title:

A Protocol to Wean From Noninvasive Mechanical Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535755
• Other study ID #: cqykdxfsdyyy2
• 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

• Ventilator Weaning

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