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Completed

NCT Number: NCT00881335

Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

85 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flutter mucus clearance device

Device

five minutes every sessions, three sessions per day

Primary outcomes

  1. Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)

    Time frame: up to 28 days

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of Cases With Antibiotics Therapy

    Time frame: up to 28 days

    antibiotics therapy is the indicators of pulmonary infection

  2. Number of Cases With Hospital Visit

    Time frame: up to 28 days

Sponsors and collaborators

Lead sponsor

Tongji University

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2009
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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