Pediatric Cardiac Output Monitoring Observational Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-02

Study Completion Date

2023-01-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing USCOM and Echocardiographic Hemodynamic Measurements in Children (CUE Study)

NCT02083172

Hemodynamically Stable Critical Illness

COMPLETED

Echocardiography in Kids Intensive Care Decision Support

NCT01821742

Fluid Responsiveness Cardiac Output

COMPLETED

Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren

NCT05919719

Circulatory Failure (Shock)

COMPLETED

Echocardiographic Analysis in Healthy Child.

NCT02056925

Healthy Child

COMPLETED NA

Fluorescence Imaging of the Parathyroid Glands of Children

NCT05917067

Childhood Thyroid Gland Carcinoma Thyroid Diseases

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemosphere 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No