Cardiac Surgery
Conditions
Brief summary
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.
Interventions
DEVICELiDCO rapid monitor
Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pulse Pressure Variability From Baseline to Post-ANH | 1 Day | The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Stroke Volume Variability From Baseline to Post ANH. | 1 Day | The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiDCO Rapid Monitor | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | LiDCO Rapid Monitor |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 21.5 years STANDARD_DEVIATION 11.018 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Difference in Pulse Pressure Variability From Baseline to Post-ANH
The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiDCO Rapid Monitor | Difference in Pulse Pressure Variability From Baseline to Post-ANH | 7.46 % variability | Standard Deviation 9.149 |
Secondary
Difference in Stroke Volume Variability From Baseline to Post ANH.
The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiDCO Rapid Monitor | Difference in Stroke Volume Variability From Baseline to Post ANH. | 4.46 % variability | Standard Deviation 5.368 |