Trial Outcomes & Findings for Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study) (NCT NCT02184169)
NCT ID: NCT02184169
Last Updated: 2020-06-04
Results Overview
Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
While mechanically ventilated, up to 14 days
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
HLHS
Patients undergoing palliative repair.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
TGA With/Without VSD
Surgical repair of TGA.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
6
|
|
Overall Study
COMPLETED
|
21
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HLHS
n=21 Participants
Patients undergoing palliative repair.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
TGA/IVS
n=6 Participants
Surgical repair of TGA.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=21 Participants
|
6 Participants
n=6 Participants
|
27 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
.1 years
STANDARD_DEVIATION .1 • n=21 Participants
|
.1 years
STANDARD_DEVIATION .1 • n=6 Participants
|
.1 years
STANDARD_DEVIATION .1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=21 Participants
|
2 Participants
n=6 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=21 Participants
|
4 Participants
n=6 Participants
|
14 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
21 Participants
n=21 Participants
|
6 Participants
n=6 Participants
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: While mechanically ventilated, up to 14 daysOxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.
Outcome measures
| Measure |
HLHS
n=21 Participants
Patients undergoing palliative repair.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
TGA With/Without VSD
n=6 Participants
Surgical repair of TGA.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
|---|---|---|
|
Oxygen Consumption
|
72 mL oxygen/min/m^2
Standard Deviation 12
|
102 mL oxygen/min/m^2
Standard Deviation 22
|
SECONDARY outcome
Timeframe: While mechanically ventilated, up to 14 daysPopulation: The average cardiac index was measured for each patient twice per day
A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.
Outcome measures
| Measure |
HLHS
n=21 Participants
Patients undergoing palliative repair.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
TGA With/Without VSD
n=6 Participants
Surgical repair of TGA.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system
|
|---|---|---|
|
Computed Cardiac Index
|
1.3 L/min/m2
Standard Deviation 0.4
|
2.2 L/min/m2
Standard Deviation 0.6
|
Adverse Events
HLHS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TGA/IVS
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place