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Clinical Trials/NCT01900990
NCT01900990
Completed
Not Applicable

A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients

Chongqing Medical University1 site in 1 country32 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Chongqing Medical University
Enrollment
32
Locations
1
Primary Endpoint
Main end-point defined as total duration of mechanical ventilation
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
October 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chongqing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Duan jun

resident physician

Chongqing Medical University

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

Outcomes

Primary Outcomes

Main end-point defined as total duration of mechanical ventilation

Time Frame: from admission to hospital to discharge from it or death

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 Outcomes

  • duration of invasive mechanical ventilation(from admission to hospital to discharge from it or death)
  • duration of extubation tracheotomy tube(from admission to hospital to discharge from it or death)
  • total duration of mechanical ventilation (invasive and non invasive)(from admission to hospital to discharge from it or death)
  • successful weaning rate(from admission to hospital to discharge from it or death)
  • ICU length of stay(from admission to hospital to discharge from it or death)
  • hospital length of stay(from admission to hospital to discharge from it or death)

Study Sites (1)

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