Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

NCT01103908 | Terminated

• 2 other identifiers: TSI-G-HCE101-5A-H2R44HL082022-02
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.

Conditions

Cardiac Output

Keywords

cardiac output; cardiopulmonary bypass; ultrasound dilution

Outcome Measures

Primary Outcomes (1)

• Cardiac output after cardiopulmonary bypass

  Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass

  Less than 10 minutes

Study Arms (1)

Pediatric cardiac output (CO) after CPB

Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.

Device: HCE101 Cardiopulmonary Support Monitor

Interventions

HCE101 Cardiopulmonary Support Monitor DEVICE

Measurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor.

Pediatric cardiac output (CO) after CPB

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.

You may qualify if:

• Pediatric patients (age \< 21 years)
• Pediatric patients undergoing surgery involving cardiopulmonary bypass

You may not qualify if:

• Patients aged \> 21 years
• Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)

Sponsors & Collaborators

• Transonic Systems Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Nikolai Krivitski, PhD, DSc

  Transonic Systems Inc.

  PRINCIPAL INVESTIGATOR

• Alistair Phillips, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)