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Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

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ClinicalTrials.gov Identifier: NCT03534986
Recruitment Status : Completed
First Posted : May 23, 2018
Results First Posted : September 6, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
International Biophysics Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cystic Fibrosis
Bronchiectasis
Interventions Device: International Biophysics AffloVest
Device: Hill-Rom The Vest
Device: Respirtech inCourage
Device: Electromed SmartVest
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm
Hide Arm/Group Description

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Respirtech inCourage: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Electromed SmartVest: High-frequency chest wall oscillation vest

Period Title: Overall Study
Started 10 10 12
Completed 10 10 10
Not Completed 0 0 2
Arm/Group Title AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm Total
Hide Arm/Group Description

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Respirtech inCourage: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Electromed SmartVest: High-frequency chest wall oscillation vest

Total of all reporting groups
Overall Number of Baseline Participants 10 10 12 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 12 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
12
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 12 participants 32 participants
28.4  (11.9) 30.6  (13.3) 34.7  (10.2) 31.7  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 12 participants 32 participants
Female
2
  20.0%
4
  40.0%
7
  58.3%
13
  40.6%
Male
8
  80.0%
6
  60.0%
5
  41.7%
19
  59.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 12 participants 32 participants
10 10 12 32
1.Primary Outcome
Title TV
Hide Description Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline AffloVest Arm Compressor Arm
Hide Arm/Group Description:
Patient Baseline Results

Devices placed on highest intensity / highest frequency

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

Compressor-type device

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: L
0.93
(0.30 to 2.32)
1.00
(0.27 to 2.28)
1.07
(0.24 to 2.69)
2.Primary Outcome
Title PEF
Hide Description Peak Expiratory Flow, a person's maximum speed of expiration
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline AffloVest Arm Compressor Arm
Hide Arm/Group Description:
Patient Baseline Results

Devices placed on highest intensity / highest frequency

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

Compressor-type device

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: L/s
8.19
(3.96 to 11.82)
8.28
(3.50 to 12.00)
8.13
(4.23 to 12.89)
3.Primary Outcome
Title FVC
Hide Description Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline AffloVest Arm Compressor Arm
Hide Arm/Group Description:
Patient Baseline Results

Devices placed on highest intensity / highest frequency

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

Compressor-type device

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: L
4.29
(2.48 to 6.57)
4.25
(2.5 to 7.42)
4.12
(2.29 to 6.73)
4.Primary Outcome
Title FEV1
Hide Description Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline AffloVest Arm Compressor Arm
Hide Arm/Group Description:
Patient Baseline Results

Devices placed on highest intensity / highest frequency

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

Compressor-type device

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: L
3.51
(2.05 to 5.54)
3.46
(2.00 to 6.19)
3.30
(1.92 to 5.83)
5.Primary Outcome
Title FEF25-75%
Hide Description Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline AffloVest Arm Compressor Arm
Hide Arm/Group Description:
Patient Baseline Results

Devices placed on highest intensity / highest frequency

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

Compressor-type device

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: L/s
3.71
(1.77 to 6.43)
3.54
(1.63 to 6.37)
3.19
(1.19 to 6.22)
Time Frame Study enrollment, approximately 2 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm
Hide Arm/Group Description

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Hill-Rom The Vest: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Respirtech inCourage: High-frequency chest wall oscillation vest

Devices placed on highest intensity / highest frequency

International Biophysics AffloVest: High-frequency chest wall oscillation vest

Electromed SmartVest: High-frequency chest wall oscillation vest

All-Cause Mortality
AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AffloVest The Vest Arm AffloVest inCourage Arm AffloVest SmartVest Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: VP of Engineering and Quality
Organization: International Biophysics Corporation
Phone: 512-814-0046
Responsible Party: International Biophysics Corporation
ClinicalTrials.gov Identifier: NCT03534986     History of Changes
Other Study ID Numbers: 2017-02
First Submitted: May 14, 2018
First Posted: May 23, 2018
Results First Submitted: August 9, 2018
Results First Posted: September 6, 2018
Last Update Posted: October 3, 2018