NCT00881335

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 20, 2012

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

1 month

First QC Date

April 14, 2009

Results QC Date

June 17, 2009

Last Update Submit

June 25, 2012

Conditions

Pulmonary Disease

Keywords

geriatricpulmonary diseasefluttersputumphysical therapy techniques

Outcome Measures

Primary Outcomes (5)

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

    up to 28 days

  • MPEF,Mean Peak Expiratory Flow

    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

    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

    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

    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 Outcomes (2)

  • Number of Cases With Antibiotics Therapy

    up to 28 days

  • Number of Cases With Hospital Visit

    up to 28 days

Study Arms (2)

control group

NO INTERVENTION

intervention

EXPERIMENTAL

Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise

Device: flutter mucus clearance device

Interventions

flutter mucus clearance deviceDEVICE

five minutes every sessions, three sessions per day

intervention

Eligibility Criteria

Age85 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20979671DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

Title
Zhang Xiangyu
Organization
Shanghai Tenth People's Hospital, Tongji University
xiangyu62@126.com
86-21-66307174

Study Officials

  • Zhang Xiangyu, MD

    Shanghai Tebth People's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, director, professor, FCCM, FCCP.

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 29, 2012

Results First Posted

June 20, 2012

Record last verified: 2012-06