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Trial Outcomes & Findings for Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®) (NCT NCT01672242)

NCT ID: NCT01672242

Last Updated: 2022-03-08

Results Overview

Change in end-expiratory lung volume from baseline arbitrarily set at 0 mL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

baseline and after 3-5 minutes after each level of flow or pressure

Results posted on

2022-03-08

Participant Flow

Normal subjects were recruited from the University of Maryland School of Medicine

Volunteers were asked briefly about their health status and given spirometry to document no evidence of obstructive airways disease or other chronic lung disease that would impact their FRC measurements with high flow nasal cannula therapy or CPAP.

Participant milestones

Participant milestones
Measure
HFNC-CPAP
High flow nasal cannula oxygen first period, followed by continuous positive airway pressure second period.
CPAP-HFNC
Continuous Positive Airway Pressure first period, followed by high flow nasal cannula second period.
Period 1
STARTED
4
2
Period 1
COMPLETED
4
2
Period 1
NOT COMPLETED
0
0
Period 2
STARTED
4
2
Period 2
COMPLETED
4
2
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Participants
n=6 Participants
Normal healthy adult volunteers
Age, Continuous
35.5 years
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants
height
71 inches
n=5 Participants
predicted body weight
75.3 kg
n=5 Participants
FEV1 (% predicted)
93 % predicted
n=5 Participants
FEV1/FVC (%)
102 ratio
n=5 Participants

PRIMARY outcome

Timeframe: baseline and after 3-5 minutes after each level of flow or pressure

Change in end-expiratory lung volume from baseline arbitrarily set at 0 mL.

Outcome measures

Outcome measures
Measure
HFNC
n=6 Participants
High flow nasal cannula oxygen 40 liters/min
CPAP
n=6 Participants
Continuous positive airway pressure 20 cm H2O
Change in End-expiratory Lung Volume
-144 mL
Standard Deviation 317
103 mL
Standard Deviation 274

Adverse Events

HFNC

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

CPAP

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

Carl Shanholtz, MD

University of Maryland School of Medicine

Phone: 410.328.8141

Results disclosure agreements

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