Pediatric ALLPOGONCT04465370

Pediatric Cardiac Output Monitoring Observational Study

An observational study of Pediatric ALL, run by Edwards Lifesciences at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Pediatric ALL
What is being tested?: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
Type of treatment: Medical device
How many people: 89 participants
Where: 3 sitesUnited States
Study dates: 2 Sep 2020to 5 Jan 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Study population: Males and Females, 12 to 18 years of age at the time of screening. Who presenting to Cardiac Catheterization Lab for right heart catheterizations.

Who may be able to join

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

Who cannot join

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)

Show all 12Show fewer

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

UF Health Shands Children's Hospital
Gainesville, Florida, 32610
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients

Conditions: Pediatric ALL
Being tested: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
Keywords: Hemodynamic Monitoring, Cardiac Output
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, ForesightDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Duration of cardiac catheterization procedure, an average of 2 hours
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
Measured: Duration of cardiac catheterization procedure, an average of 2 hours
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
Measured: Duration of cardiac catheterization procedure, an average of 2 hours
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
Measured: Duration of cardiac catheterization procedure, an average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 20205 Jan 2023

First posted10 Jul 2020
Study start2 Sep 2020
Primary completion5 Jan 2023
Study completion5 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric ALLStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465370
Sponsor's protocol ID: 2019-08
Acronym: POGO
Status last verified: Sep 2024
First submitted: 7 Jul 2020
Last updated: 18 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Tume SC, O'Byrne ML, Fudge C, Anders MM, Gupta D. Validation of Minimally Invasive and Noninvasive Hemodynamic Monitoring in Adolescents: The Pediatric Cardiac Output Monitoring Observational (POGO) Study. Pediatr Crit Care Med. 2026 Aug 1;27(8):986-997. doi: 10.1097/PCC.0000000000003986. Epub 2026 Aug 6.
PubMed 42560156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pediatric ALL trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients
ClinicalTrials.gov ID: NCT04465370
Acronym / sponsor ID: POGO / 2019-08
Conditions: Pediatric ALL
Keywords: Hemodynamic Monitoring, Cardiac Output
Study type: Observational
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 2 Sep 2020 (actual)
Primary completion: 5 Jan 2023 (actual)
Study completion: 5 Jan 2023 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 18 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Males and Females, 12 to 18 years of age at the time of screening. Who presenting to Cardiac Catheterization Lab for right heart catheterizations.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, ForesightA 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.	Device	–

Primary outcome

Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Time frame: 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
Time frame: 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
Time frame: 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
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Time frame: 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

Results and safety

Results posted to the registry on 18 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device: Hemosphere Advanced Monitoring System, ClearSight, Swan-Ganz Catheter, Flotrac, Foresight	89	60

Primary outcome: Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

Time frame: Duration of cardiac catheterization procedure, an average of 2 hours. Mean (95% Confidence Interval). Unit: L/min

Measure	Swan-Ganz ICO vs. FloTrac CO - Bias n = 60
Value	0.49 (0.30 to 0.68)

Population analysed: 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.

Primary outcome: Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

Time frame: Duration of cardiac catheterization procedure, an average of 2 hours. Mean (95% Confidence Interval). Unit: L/min

Measure	Swan-Gan ICO vs. FloTrac CO - Precision n = 60
Value	1.11 (0.92 to 1.30)

Primary outcome: Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

Time frame: Duration of cardiac catheterization procedure, an average of 2 hours. Mean (95% Confidence Interval). Unit: L/min

Measure	Swan-Ganz ICO vs. ClearSight CO - Bias n = 60
Value	0.41 (0.21 to 0.61)

Primary outcome: Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

Time frame: Duration of cardiac catheterization procedure, an average of 2 hours. Mean (95% Confidence Interval). Unit: L/min

Measure	Swan-Ganz ICO vs. ClearSight CO - Precision n = 60
Value	1.11 (0.92 to 1.30)

Adverse events

Time frame: Duration of the procedure through 30 days after procedure, plus or minus 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Population	5 of 89 (5.6%)	0 of 89 (0%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42560156Tume SC, O'Byrne ML, Fudge C, Anders MM, Gupta D. Validation of Minimally Invasive and Noninvasive Hemodynamic Monitoring in Adolescents: The Pediatric Cardiac Output Monitoring Observational (POGO) Study. Pediatr Crit Care Med. 2026 Aug 1;27(8):986-997. doi: 10.1097/PCC.0000000000003986. Epub 2026 Aug 6.

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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric ALL, run by Edwards Lifesciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output (time frame: Duration of cardiac catheterization procedure, an average of 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04465370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.