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Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Noninvasive ventilation weaning
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 18 years
  • tracheotomy mechanical ventilation patients

Exclusion Criteria:

  • pregnancy
  • respiratory and hemodynamic instability
  • Recent oral，nasal，facial or cranial trauma or surgery
  • contra-indications for nasal or facial mask (facial skin lesions,...)
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction
  • unconscious patients
  • non cooperative patient

Sites / Locations

  • The First Affiliated Hospital ,Chongqing Medical Univercity
  • The First Affiliated Hospital ,Chongqing Medical Univercity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Noninvasive ventilation weaning

Conventional weaning

Arm Description

Patients in this group were weaned by noninvasive ventilation

Patients in this group were weaned by conventional stratiges.

Outcomes

Primary Outcome Measures

Main end-point defined as total duration of mechanical ventilation
The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.

Secondary Outcome Measures

duration of invasive mechanical ventilation
The duration of invasive mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
duration of extubation tracheotomy tube
The duration of extubation tracheotomy tube was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
total duration of mechanical ventilation (invasive and non invasive)
The total duration of mechanical ventilation (invasive and non invasive) was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
successful weaning rate
The sucessful weaning rate was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
ICU length of stay
The ICU lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
hospital length of stay
The hospital lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.

Full Information

First Posted
July 26, 2010
Last Updated
July 13, 2013
Sponsor
Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01900990
Brief Title
Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients
Official Title
A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.
Detailed Description
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive ventilation weaning
Arm Type
Experimental
Arm Description
Patients in this group were weaned by noninvasive ventilation
Arm Title
Conventional weaning
Arm Type
No Intervention
Arm Description
Patients in this group were weaned by conventional stratiges.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation weaning
Other Intervention Name(s)
capping tracheotomy tube
Intervention Description
We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff
Primary Outcome Measure Information:
Title
Main end-point defined as total duration of mechanical ventilation
Description
The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Secondary Outcome Measure Information:
Title
duration of invasive mechanical ventilation
Description
The duration of invasive mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Title
duration of extubation tracheotomy tube
Description
The duration of extubation tracheotomy tube was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Title
total duration of mechanical ventilation (invasive and non invasive)
Description
The total duration of mechanical ventilation (invasive and non invasive) was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Title
successful weaning rate
Description
The sucessful weaning rate was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Title
ICU length of stay
Description
The ICU lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death
Title
hospital length of stay
Description
The hospital lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Time Frame
from admission to hospital to discharge from it or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years tracheotomy mechanical ventilation patients Exclusion Criteria: pregnancy respiratory and hemodynamic instability Recent oral，nasal，facial or cranial trauma or surgery contra-indications for nasal or facial mask (facial skin lesions,...) recent history of upper gastro-intestinal surgery recent history of myocardial infarction unconscious patients non cooperative patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duan Jun
Organizational Affiliation
The First Affiliated Hospital,Chongqing Medical Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital ,Chongqing Medical Univercity
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Affiliated Hospital ,Chongqing Medical Univercity
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
40016
Country
China

12. IPD Sharing Statement

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Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

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