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Trial Outcomes & Findings for Electro Flo 5000 and Vest Therapy (NCT NCT02277626)

NCT ID: NCT02277626

Last Updated: 2016-01-12

Results Overview

Sputum was collected in pre-measured cups in a blinded fashion

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

End of study visit per intervention

Results posted on

2016-01-12

Participant Flow

Participant milestones

Participant milestones
Measure
Vest First Then ElectroFlo
Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000. EnCourage Vest System: Airway Clearance Device
ElectroFlo First Then Vest
Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest. Electro Flo 5000: Airway clearance device
Overall Study
STARTED
6
9
Overall Study
COMPLETED
6
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electro Flo 5000 and Vest Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Number of Participants
n=15 Participants
Age, Continuous
33.33 years
n=99 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
Sex: Female, Male
Male
7 Participants
n=99 Participants

PRIMARY outcome

Timeframe: End of study visit per intervention

Sputum was collected in pre-measured cups in a blinded fashion

Outcome measures

Outcome measures
Measure
Vest
n=15 Participants
VEST Arm Incourage Vest System: Airway Clearance Device
Elecflo Arm
n=15 Participants
Elecflo Arm Electro Flo 5000: Airway clearance device
Wet Sputum Weight
3.8 grams
Interval 1.1 to 6.5
4.6 grams
Interval 0.8 to 8.4

PRIMARY outcome

Timeframe: End of study visit per intervention

Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.

Outcome measures

Outcome measures
Measure
Vest
n=15 Participants
VEST Arm Incourage Vest System: Airway Clearance Device
Elecflo Arm
n=15 Participants
Elecflo Arm Electro Flo 5000: Airway clearance device
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
72.43 percentage of predicted value
Interval 55.81 to 89.05
72.93 percentage of predicted value
Interval 54.89 to 90.97

PRIMARY outcome

Timeframe: End of study visit per intervention

Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.

Outcome measures

Outcome measures
Measure
Vest
n=15 Participants
VEST Arm Incourage Vest System: Airway Clearance Device
Elecflo Arm
n=15 Participants
Elecflo Arm Electro Flo 5000: Airway clearance device
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
75.8 percentage of predicted value
Interval 57.36 to 94.24
75.73 percentage of predicted value
Interval 58.56 to 92.9

PRIMARY outcome

Timeframe: End of study visit per intervention

Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)

Outcome measures

Outcome measures
Measure
Vest
n=15 Participants
VEST Arm Incourage Vest System: Airway Clearance Device
Elecflo Arm
n=15 Participants
Elecflo Arm Electro Flo 5000: Airway clearance device
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
3.93 units on a scale
Interval 0.84 to 7.02
2.67 units on a scale
Interval 0.49 to 4.85

SECONDARY outcome

Timeframe: End of study visit per intervention

Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry

Outcome measures

Outcome measures
Measure
Vest
n=15 Participants
VEST Arm Incourage Vest System: Airway Clearance Device
Elecflo Arm
n=15 Participants
Elecflo Arm Electro Flo 5000: Airway clearance device
Dry Sputum Weight
0.15 gram
Interval 0.0 to 0.31
0.18 gram
Interval 0.0 to 0.43

Adverse Events

Vest Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ElectroFlo Arm

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

Carlos Milla, MD

Stanford University

Phone: 650-723-5193

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place