Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

Study Overview
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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.

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

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Noninvasive ventilation weaning


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive ventilation weaning<br>Patients in this group were weaned by noninvasive ventilation | Device: Noninvasive ventilation weaning<br>* We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff<br>* Other names: capping tracheotomy tube;|
| No Intervention: Conventional weaning<br>Patients in this group were weaned by conventional stratiges. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from admission to hospital to discharge from it or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from admission to hospital to discharge from it or death | 
| 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. | from admission to hospital to discharge from it or death | 
| 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. | from admission to hospital to discharge from it or death | 
| 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. | from admission to hospital to discharge from it or death | 
| 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. | from admission to hospital to discharge from it or death | 
| 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. | from admission to hospital to discharge from it or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy