Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00881335
Recruitment Status : Completed
First Posted : April 15, 2009
Results First Posted : June 20, 2012
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University

Tracking Information
First Submitted Date  ICMJE April 14, 2009
First Posted Date  ICMJE April 15, 2009
Results First Submitted Date  ICMJE June 17, 2009
Results First Posted Date  ICMJE June 20, 2012
Last Update Posted Date June 29, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
  • Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) [ Time Frame: up to 28 days ]
  • MPEF,Mean Peak Expiratory Flow [ Time Frame: up to 28 days ]
    indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
  • FEV1, Forced Expiratory Volume at First Second [ Time Frame: up to 28 days ]
    indicators of pulmonary function, for example, FEV1(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
  • FVC, Forced Vital Capacity [ Time Frame: up to 28 days ]
    indicators of pulmonary function, for example, FVC(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
  • FEV1/FVC%, the Ratio of FEV1 to FVC [ Time Frame: up to 28 days ]
    indicators of pulmonary function, All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Days of fever (body temperature reach 38 degree celsius or higher), improvement of pulmonary function [ Time Frame: one month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • Number of Cases With Antibiotics Therapy [ Time Frame: up to 28 days ]
    antibiotics therapy is the indicators of pulmonary infection
  • Number of Cases With Hospital Visit [ Time Frame: up to 28 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Days of antibiotics therapy, times of hospital visit [ Time Frame: one month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Official Title  ICMJE Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Brief Summary The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.
Detailed Description Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Pulmonary Disease
Intervention  ICMJE Device: flutter mucus clearance device
five minutes every sessions, three sessions per day
Study Arms  ICMJE
  • No Intervention: control group
  • Experimental: intervention
    Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
    Intervention: Device: flutter mucus clearance device
Publications * Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • available to perform the device, the elders in geracomium
  • male and female
  • aging 85 years or more

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
  • active hemoptysis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 85 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881335
Other Study ID Numbers  ICMJE SHDC12007211-O
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhang Xiangyu, Tongji University
Study Sponsor  ICMJE Tongji University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhang Xiangyu, MD Shanghai Tebth People's Hospital
PRS Account Tongji University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP