Application and Generalization of Flutter Mucus Clearance Device
1 other identifier
interventional
356
1 country
1
Brief Summary
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 2, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 22, 2012
June 1, 2012
1.1 years
January 2, 2009
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
one year
Secondary Outcomes (1)
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
one year
Study Arms (2)
1
EXPERIMENTALflutter mucus clearance device
2
NO INTERVENTIONObservation
Interventions
Eligibility Criteria
You may qualify if:
- Pulmonary department: available to perform the device, in-hospital patients
- Male and female
- Age: 45 - 85 years
- Chronic bronchitis, COPD
- Thoracic surgery department and surgical department (upper abdomen):
- Patients with endotracheal intubation of general anesthesia
- Age: 40-75 years
You may not qualify if:
- Not available to perform the procedure
- Untreated pneumothorax
- Diffusion interstitial lung disease
- Acute coronary syndrome
- Third stage hypertension
- Advanced cancer
- Severe heart, liver, renal , blood system and endocrine system dysfunction
- Noninvasive mechanical ventilation more than 6 hrs per day
- Patients with invasive ventilation and cannot weaning and extubation within 48 hours
- Active hemoptysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Related Publications (1)
Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.
PMID: 25534580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Xiangyu, MD
Shanghai 10th People's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 2, 2009
First Posted
January 5, 2009
Study Start
January 1, 2009
Primary Completion
February 1, 2010
Study Completion
March 1, 2010
Last Updated
June 22, 2012
Record last verified: 2012-06