Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

NCT01900990 | Completed DMC

• 1 other identifier: CQYKDXFSDYYY
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Failure

Keywords

Noninvasive Positive Pressure Ventilation; Invasive Positive Pressure Ventilation; tracheotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• duration of invasive mechanical ventilation

  from admission to hospital to discharge from it or death

• duration of extubation tracheotomy tube

  from admission to hospital to discharge from it or death

• total duration of mechanical ventilation (invasive and non invasive)

  from admission to hospital to discharge from it or death

• successful weaning rate

  from admission to hospital to discharge from it or death

• ICU length of stay

  from admission to hospital to discharge from it or death

Study Arms (2)

Noninvasive ventilation weaning

EXPERIMENTAL

Patients in this group were weaned by noninvasive ventilation

Device: Noninvasive ventilation weaning

Conventional weaning

NO INTERVENTION

Patients in this group were weaned by conventional stratiges.

Interventions

Noninvasive ventilation weaning DEVICE

We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff

Also known as: capping tracheotomy tube

Noninvasive ventilation weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• tracheotomy mechanical ventilation patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (2)

The First Affiliated Hospital ,Chongqing Medical Univercity

Chongqing, Chongqing Municipality, 400016, China

Location

The First Affiliated Hospital ,Chongqing Medical Univercity

Chongqing, Chongqing Municipality, 40016, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Duan Jun

  The First Affiliated Hospital,Chongqing Medical Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 17, 2013
• Study Start: July 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

CN (2)