Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

June 25, 2012 updated by: Zhang Xiangyu, Tongji University
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

85 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: intervention
Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
Device: flutter mucus clearance device
five minutes every sessions, three sessions per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Time Frame: up to 28 days
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.
up to 28 days
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.
up to 28 days
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.
up to 28 days
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.
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cases With Antibiotics Therapy
Time Frame: up to 28 days
antibiotics therapy is the indicators of pulmonary infection
up to 28 days
Number of Cases With Hospital Visit
Time Frame: up to 28 days
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji University

Investigators

  • Principal Investigator: Zhang Xiangyu, MD, Shanghai Tebth People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12007211-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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