Clinical trial NCT01900990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Noninvasive Positive Pressure Ventilation
Invasive Positive Pressure Ventilation
tracheotomy
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Main end-point defined as total duration of mechanical ventilation
timeFrame: from admission to hospital to discharge from it or death
Secondary outcomes:
measure: duration of invasive mechanical ventilation
timeFrame: from admission to hospital to discharge from it or death
measure: duration of extubation tracheotomy tube
timeFrame: from admission to hospital to discharge from it or death
measure: total duration of mechanical ventilation (invasive and non invasive)
timeFrame: from admission to hospital to discharge from it or death
measure: successful weaning rate
timeFrame: from admission to hospital to discharge from it or death
measure: ICU length of stay
timeFrame: from admission to hospital to discharge from it or death
measure: hospital length of stay
timeFrame: from admission to hospital to discharge from it or death
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital ,Chongqing Medical Univercity
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital ,Chongqing Medical Univercity
state: Chongqing
Study officials:
affiliation: The First Affiliated Hospital,Chongqing Medical Univercity
name: Duan Jun
role: PRINCIPAL_INVESTIGATOR
References: