A Protocol to Wean From Noninvasive Mechanical Ventilation

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

Study Overview

• Status: Terminated
• Conditions: Ventilator Weaning
• Intervention / Treatment: Device: protocol; Other: physician's orders

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • ChongQing, Chongqing, China, 400016
      • The first affiated hospital, chongqing medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: protocol group; This group patients are weaned as the protocol which the investigators described.	Device: protocol; In this group, the patients were weaned as the protocol.; Other Names: In this group, the patients were weaned as the protocol.
OTHER: clinicians' order group; This group patients are weaned as the clinicians' order.	Other: physician's orders; In this group, the patients were weaned as the clinicians' order.; Other Names: In this group, the patients were weaned as the clinicians' order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Duan jun
• Investigators: Principal Investigator: Jun Duan, The first affiliated hospital, Chongqing medical hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: February 11, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (ESTIMATE): February 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: ventilator weaning; noninvasive mechanical ventilation
• Other Study ID Numbers: cqykdxfsdyyy2