Pediatric ALL
Conditions
Keywords
Hemodynamic Monitoring, Cardiac Output
Brief summary
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.
Interventions
DEVICEHemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.
Sponsors
Edwards Lifesciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are 12 to 18 years of age * Subjects who have signed the Informed Consent Form * Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures * For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation * Subjects with planned pressure monitoring with an arterial line
Exclusion criteria
* Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy); * Subjects with contraindications for Arterial Line Placement; * Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease). * Subjects with a physical site area too limited for proper Sensor placement * Subjects with finger size less than the smallest finger cuff size * Documented ≥ moderate pulmonary hypertension (PAPm \> 25mmHg, PVRI \> 3.0 WUxm2) * Presence of intracardiac shunting (i.e., ASD, VSD) * Aorto-pulmonary collaterals * ≥ Moderate tricuspid regurgitation, per echocardiogram criteria * \> Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria * Persistent cardiac arrythmias during the cardiac catheterization period (\> 3min) * Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | Duration of cardiac catheterization procedure, an average of 2 hours | Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis |
| Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | Duration of cardiac catheterization procedure, an average of 2 hours | Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis |
| Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | Duration of cardiac catheterization procedure, an average of 2 hours | Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis |
| Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | Duration of cardiac catheterization procedure, an average of 2 hours | Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis |
Countries
United States
Participant flow
Recruitment details
There were a total of 89 subjects enrolled. After applying the pre-determined rejection criteria for hemodynamic instability or poor signal quality, there were 60 Evaluable Pivotal Subjects.
Participants by arm
| Arm | Count |
|---|---|
| Device: Hemosphere Advanced Monitoring System, ClearSight, Swan-Ganz Catheter, Flotrac, Foresight A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan. | 89 |
| Total | 89 |
Baseline characteristics
| Characteristic | Device: Hemosphere Advanced Monitoring System, ClearSight, Swan-Ganz Catheter, Flotrac, Foresight |
|---|---|
| Age, Categorical <=18 years | 89 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.3 Years STANDARD_DEVIATION 1.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 89 |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 5 / 89 |
Outcome results
Primary
Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Population: After applying the pre-determined data exclusion criteria for hemodynamic instability or poor signal quality, there were 60 Evaluable Pivotal Subjects in each of the comparison groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swan-Ganz ICO vs. FloTrac CO - Bias | Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | 0.41 L/min |
Primary
Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Population: After applying the pre-determined data exclusion criteria for hemodynamic instability or poor signal quality, there were 60 Evaluable Pivotal Subjects in each of the comparison groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swan-Ganz ICO vs. FloTrac CO - Bias | Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | 0.49 L/min |
Primary
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Population: After applying the pre-determined data exclusion criteria for hemodynamic instability or poor signal quality, there were 60 Evaluable Pivotal Subjects in each of the comparison groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swan-Ganz ICO vs. FloTrac CO - Bias | Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | 1.11 L/min |
Primary
Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Population: After applying the pre-determined data exclusion criteria for hemodynamic instability or poor signal quality, there were 60 Evaluable Pivotal Subjects in each of the comparison groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swan-Ganz ICO vs. FloTrac CO - Bias | Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output | 1.11 L/min |