Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900990
• Other study ID #: CQYKDXFSDYYY
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: July 13, 2013
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: July 2013
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive ventilation weaning
We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff

Locations

Country	Name	City	State
China	The First Affiliated Hospital ,Chongqing Medical Univercity	Chongqing	Chongqing
China	The First Affiliated Hospital ,Chongqing Medical Univercity	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes