A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

NCT01499615 | Completed

• 1 other identifier: 2010-P-002709/1; MGH
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices. Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.

Conditions

Children Receiving General Anesthesia

Keywords

adverse events; adverse cardiovascular events; early warning

Outcome Measures

Primary Outcomes (1)

• Correlate adverse cardiovascular events in children under anesthesia with the cardiac output device and standard anesthesia monitors

  We plan to record all physiologic data from approximately 400 children under anesthesia and correlate adverse cardiovascular events determined by this new cardiac output device with standard anesthesia monitors

  approximately 18 months

Secondary Outcomes (1)

• determine if this device provides additonal safety for specific subgroups of pediatric patients under anesthesia e.g., those undergoing laparosopic procedures or procedures involving significant blood loss, neonates

  approximatley 18 months

Study Arms (1)

children undergoing general anesthesia

The intervention was the application of 4 ekg electrodes so as to non-invasivly measure cardiac output

Device: cardiac monitor

Interventions

cardiac monitor DEVICE

All children receive the same intervention which is the application of the 4 ekg electrodes

children undergoing general anesthesia

Eligibility Criteria

• Age: 1 Hour - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

neonates to teenagers

You may qualify if:

• All children presenting to our operating rooms for general anesthesia

You may not qualify if:

• Cardiac surgery, open chest procedures

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• August DA, Sui J, Cote CJ. Unintentional epidural injection of 88 mug.kg(-1) of epinephrine. Paediatr Anaesth. 2014 Nov;24(11):1185-7. doi: 10.1111/pan.12503. Epub 2014 Aug 11.

  PMID: 25130947 DERIVED

• Cote CJ, Sui J, Anderson TA, Bhattacharya ST, Shank ES, Tuason PM, August DA, Zibaitis A, Firth PG, Fuzaylov G, Leeman MR, Mai CL, Roberts JD Jr. Continuous noninvasive cardiac output in children: is this the next generation of operating room monitors? Initial experience in 402 pediatric patients. Paediatr Anaesth. 2015 Feb;25(2):150-9. doi: 10.1111/pan.12441. Epub 2014 Jun 10.

  PMID: 24916144 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Divisionof Pediatric Anesthesia

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)