Application and Generalization of Flutter Mucus Clearance... | NCT00816881

Studies
Application and Generalization of Flutter Mucus Clearance Device

NCT00816881

Sponsor

Tongji University

Status

Completed

Last Update Posted

Jun 22, 2012Estimated

Enrollment

356Actual

Phase

Not Applicable

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

flutter mucus clearance device

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 2, 2009

First Submission Date that Met QC Criteria

Jan 2, 2009

First Posted Date

Jan 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2012

Last Update Posted Date

Jun 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

356Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	flutter mucus clearance device	Device: flutter mucus clearance device
2	No Intervention	Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
flutter mucus clearance device	Device	five minutes every session, four sessions per day	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital		one year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhang Xiangyu, MD	Shanghai 10th People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Tenth People's Hospital		Shanghai	Shanghai Municipality	200072	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25534580	Derived	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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease