Trial Outcomes & Findings for Minimally Invasive Cardiac Output Monitoring Device (NCT NCT01675063)
NCT ID: NCT01675063
Last Updated: 2017-05-08
Results Overview
The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.
COMPLETED
NA
77 participants
8 hours post cardiac surgery
2017-05-08
Participant Flow
Participant milestones
| Measure |
Retia Non-Invasive Sensors
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.
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|---|---|
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Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minimally Invasive Cardiac Output Monitoring Device
Baseline characteristics by cohort
| Measure |
Retia Non-Invasive Sensors
n=77 Participants
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hours post cardiac surgeryPopulation: patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.
The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.
Outcome measures
| Measure |
Retia Non-Invasive Sensors
n=77 Participants
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.
|
|---|---|
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Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output
analyzable data obtained
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75 Participants
|
|
Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output
data flawed and unable to analyze
|
2 Participants
|
Adverse Events
Retia Non-Invasive Sensors
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 The PI is not involved with the ultimate analysis of the data which is to be used for proprietary algorithm development. The PI was engaged with his opinion on algorithm development and review of waveform data.
- Publication restrictions are in place
Restriction type: OTHER