Trial Outcomes & Findings for Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function (NCT NCT00881335)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

up to 28 days

Results posted on

2012-06-29

Participant Flow

recuitment period: April 19th, May 17th location: Redsun geracomium

Participant milestones

Participant milestones
Measure	Intervention Group all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group without any intervention
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group without any intervention
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=30 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=30 Participants without any intervention	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age Continuous	86.81 years STANDARD_DEVIATION 2.06 • n=5 Participants	87.57 years STANDARD_DEVIATION 2.95 • n=7 Participants	87.20 years STANDARD_DEVIATION 2.56 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 28 days

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)	0 participants	2 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
MPEF,Mean Peak Expiratory Flow	117.59 L/min Standard Deviation 50.39	103.93 L/min Standard Deviation 41.53

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
FEV1, Forced Expiratory Volume at First Second	1.01 L Standard Deviation 0.37	1.02 L Standard Deviation 0.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
FVC, Forced Vital Capacity	2.06 L Standard Deviation 0.73	1.77 L Standard Deviation 0.63

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
FEV1/FVC%, the Ratio of FEV1 to FVC	50.67 ratios Standard Deviation 16.83	59.04 ratios Standard Deviation 13.82

SECONDARY outcome

Timeframe: up to 28 days

antibiotics therapy is the indicators of pulmonary infection

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
Number of Cases With Antibiotics Therapy	1 participants	3 participants

SECONDARY outcome

Timeframe: up to 28 days

Outcome measures

Outcome measures
Measure	Intervention Group n=27 Participants all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.	Control Group n=28 Participants without any intervention
Number of Cases With Hospital Visit	2 participants	3 participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhang Xiangyu

Shanghai Tenth People's Hospital, Tongji University

Phone: 86-21-66307174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60