A Protocol to Wean From Noninvasive Mechanical Ventilation

Study Overview
=================
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.

Official Title
-----------------
A Protocol to Wean From Noninvasive Mechanical Ventilation

Conditions
-----------------
Ventilator Weaning

Intervention / Treatment
-----------------
* Device: protocol
* Other: physician's orders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: noninvasive mechanical ventilation > 24 hours. age >18 years Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: protocol group<br>This group patients are weaned as the protocol which the investigators described. | Device: protocol<br>* In this group, the patients were weaned as the protocol.<br>* Other names: In this group, the patients were weaned as the protocol.;|
| Other: clinicians' order group<br>This group patients are weaned as the clinicians' order. | Other: physician's orders<br>* In this group, the patients were weaned as the clinicians' order.<br>* 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive mechanical ventilation, ventilator weaning