Back to resultsApplication and Generalization of Flutter Mucus Clearance Device
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
flutter mucus clearance device
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, flutter, airway clearance, sputum, Physical Therapy Techniques
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- Shanghai Tenth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
flutter mucus clearance device
Observation
Outcomes
Primary Outcome Measures
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
Secondary Outcome Measures
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00816881
Brief Title
Application and Generalization of Flutter Mucus Clearance Device
Official Title
Application and Generalization of Flutter Mucus Clearance Device
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.
Detailed Description
Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, flutter, airway clearance, sputum, Physical Therapy Techniques
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
flutter mucus clearance device
Arm Title
2
Arm Type
No Intervention
Arm Description
Observation
Intervention Type
Device
Intervention Name(s)
flutter mucus clearance device
Intervention Description
five minutes every session, four sessions per day
Primary Outcome Measure Information:
Title
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
Time Frame
one year
Secondary Outcome Measure Information:
Title
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Xiangyu, MD
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25534580
Citation
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.
Results Reference
derived
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Application and Generalization of Flutter Mucus Clearance Device
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