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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Pulmonary Disease
Intervention Device: flutter mucus clearance device
Enrollment 60
Recruitment Details recuitment period: April 19th, May 17th location: Redsun geracomium
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. without any intervention
Period Title: Overall Study
Started 30 30
Completed 27 [1] 28 [2]
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             3             2
[1]
3 participants did not complete the period
[2]
2 participants did not complete the period
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. without any intervention Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
30
 100.0%
30
 100.0%
60
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
86.81  (2.06) 87.57  (2.95) 87.20  (2.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
21
  70.0%
24
  80.0%
45
  75.0%
Male
9
  30.0%
6
  20.0%
15
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: participants
0 2
2.Primary Outcome
Title MPEF,Mean Peak Expiratory Flow
Hide Description 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.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: L/min
117.59  (50.39) 103.93  (41.53)
3.Primary Outcome
Title FEV1, Forced Expiratory Volume at First Second
Hide Description

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.

Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: L
1.01  (0.37) 1.02  (0.35)
4.Primary Outcome
Title FVC, Forced Vital Capacity
Hide Description

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.

Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: L
2.06  (0.73) 1.77  (0.63)
5.Primary Outcome
Title FEV1/FVC%, the Ratio of FEV1 to FVC
Hide Description

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.

Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: ratios
50.67  (16.83) 59.04  (13.82)
6.Secondary Outcome
Title Number of Cases With Antibiotics Therapy
Hide Description antibiotics therapy is the indicators of pulmonary infection
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: participants
1 3
7.Secondary Outcome
Title Number of Cases With Hospital Visit
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
without any intervention
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: participants
2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. without any intervention
All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zhang Xiangyu
Organization: Shanghai Tenth People's Hospital, Tongji University
Phone: 86-21-66307174
EMail: xiangyu62@126.com
Layout table for additonal information
Responsible Party: Zhang Xiangyu, Tongji University
ClinicalTrials.gov Identifier: NCT00881335    
Other Study ID Numbers: SHDC12007211-O
First Submitted: April 14, 2009
First Posted: April 15, 2009
Results First Submitted: June 17, 2009
Results First Posted: June 20, 2012
Last Update Posted: June 29, 2012