Clinical trial · Observational
Pediatric Cardiac Output Monitoring Observational Study
A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients
NCT04465370CI-TRIAL-00082655POGOcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
- timeFrame
- Duration of cardiac catheterization procedure, an average of 2 hours
- description
- Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
- measure
- Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
- timeFrame
- Duration of cardiac catheterization procedure, an average of 2 hours
- description
- Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
- measure
- Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
- timeFrame
- Duration of cardiac catheterization procedure, an average of 2 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDTume 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. PMID 42560156