Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

NCT ID: NCT01900990

Last Updated: 2013-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Noninvasive ventilation weaning

Patients in this group were weaned by noninvasive ventilation

Group Type EXPERIMENTAL

Noninvasive ventilation weaning

Intervention Type DEVICE

We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff

Conventional weaning

Patients in this group were weaned by conventional stratiges.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Noninvasive ventilation weaning

We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff

Intervention Type DEVICE

Other Intervention Names

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capping tracheotomy tube

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Duan jun

resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duan Jun

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital,Chongqing Medical Univercity

Locations

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The First Affiliated Hospital ,Chongqing Medical Univercity

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital ,Chongqing Medical Univercity

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CQYKDXFSDYYY

Identifier Type: -

Identifier Source: org_study_id

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