Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Noninvasive ventilation weaning

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital ,Chongqing Medical Univercity
    • Chongqing, Chongqing, China, 40016
      • The First Affiliated Hospital ,Chongqing Medical Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Principal Investigator: Duan Jun, The First Affiliated Hospital,Chongqing Medical Univercity

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 13, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 13, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: tracheotomy; Noninvasive Positive Pressure Ventilation; Invasive Positive Pressure Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CQYKDXFSDYYY