Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: Noninvasive ventilation weaning

• Registration Number: NCT01900990
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-07-26
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-13
• Last Update Submitted: 2013-07-13
• Study First Posted: 2013-07-17
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation weaning	Noninvasive ventilation weaning	Patients in this group were weaned by noninvasive ventilation

Primary Outcome Measures

Name	Time	Method
Main end-point defined as total duration of mechanical ventilation	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 Outcome Measures

Name	Time	Method
duration of invasive mechanical ventilation	from admission to hospital to discharge from it or death	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	from admission to hospital to discharge from it or death	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)	from admission to hospital to discharge from it or death	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	from admission to hospital to discharge from it or death	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	from admission to hospital to discharge from it or death	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	from admission to hospital to discharge from it or death	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.

Trial Locations

Locations (1)

The First Affiliated Hospital ,Chongqing Medical Univercity; 🇨🇳 Chongqing, Chongqing, China