Trial Outcomes & Findings for Pediatric Cardiac Output Monitoring Observational Study (NCT NCT04465370)

Last Updated: 2024-11-18

Results Overview

Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Recruitment status

COMPLETED

Target enrollment

89 participants

Primary outcome timeframe

Duration of cardiac catheterization procedure, an average of 2 hours

Results posted on

2024-11-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	89
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Cardiac Output Monitoring Observational Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device: Hemosphere Advanced Monitoring System, ClearSight, Swan-Ganz Catheter, Flotrac, Foresight n=89 Participants 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.
Age, Categorical <=18 years	89 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.3 Years STANDARD_DEVIATION 1.93 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	21 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Outcome measures

Outcome measures
Measure	Swan-Ganz ICO vs. FloTrac CO - Bias n=60 Participants Group of pediatric subjects aged 12-18 comparing Swan-Ganz intermittent CO \[SG-ICO\] to FloTrac CO \[FTCO\].
Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output	0.49 L/min Interval 0.3 to 0.68

PRIMARY outcome

Timeframe: 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.

Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Outcome measures

Outcome measures
Measure	Swan-Ganz ICO vs. FloTrac CO - Bias n=60 Participants Group of pediatric subjects aged 12-18 comparing Swan-Ganz intermittent CO \[SG-ICO\] to FloTrac CO \[FTCO\].
Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output	1.11 L/min Interval 0.92 to 1.3

PRIMARY outcome

Timeframe: 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.

Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Outcome measures

Outcome measures
Measure	Swan-Ganz ICO vs. FloTrac CO - Bias n=60 Participants Group of pediatric subjects aged 12-18 comparing Swan-Ganz intermittent CO \[SG-ICO\] to FloTrac CO \[FTCO\].
Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output	0.41 L/min Interval 0.21 to 0.61

PRIMARY outcome

Timeframe: 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.

Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Outcome measures

Outcome measures
Measure	Swan-Ganz ICO vs. FloTrac CO - Bias n=60 Participants Group of pediatric subjects aged 12-18 comparing Swan-Ganz intermittent CO \[SG-ICO\] to FloTrac CO \[FTCO\].
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output	1.11 L/min Interval 0.92 to 1.3

Adverse Events

Treatment Population

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Population n=89 participants at risk All subjects were provided with Swan-Ganz, FloTrac, and ClearSight monitors.
Cardiac disorders Admission For Atg Treatment For Rejection	1.1% 1/89 • Number of events 1 • Duration of the procedure through 30 days after procedure, plus or minus 14 days
Cardiac disorders Transplant Rejection Amr Grade 2	1.1% 1/89 • Number of events 1 • Duration of the procedure through 30 days after procedure, plus or minus 14 days
General disorders Cardiac	1.1% 1/89 • Number of events 1 • Duration of the procedure through 30 days after procedure, plus or minus 14 days
Immune system disorders Other	2.2% 2/89 • Number of events 2 • Duration of the procedure through 30 days after procedure, plus or minus 14 days

Other adverse events

Adverse event data not reported

Additional Information

Cristina Johnson

Edwards Lifesciences

Phone: 888.713.1564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place