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

NCT ID: NCT01499615

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 402 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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.

Detailed Description

All children undergoing both elective and emergent surgery or GI endoscopy evaluation will be candidates for study. Since this is an FDA approved monitor that is approved across all age groups and since this is an additional monitor over those routinely used in the operating room and since it is noninvasive (4 EKG leads) verbal consent documented in the record has been approved by the IRB.

After informed verbal consent, either the research coordinator or a study physician will populate the cardiac output device with the child's age, weight, gender and height. For older children the required 4 EKG electrodes will be applied prior to induction of anesthesia (2 on the left side of the neck and 2 on the left chest at the level of the sternal depression; for neonates and infants one electrode can be applied to the forehead and the other to a thigh if application space is a problem). For children who are not able to be cooperative, as with most of our monitors the electrodes will be placed after induction of general anesthesia. An automated anesthesia record will continuously record heart rate, respiratory rate, oxygen saturation, systolic and diastolic pressures. The monitor will be set to perform these measurements every 1 minute. New software has been written that enables us to interface the cardiac output device with our automated anesthesia record. Thus the data from the cardiac output device will be inserted on the anesthesia record at approximate 1 minute intervals in real time. The data from the anesthesia records will later be downloaded as a unit to Excel spread sheets for later analysis. All demographic data will also be downloaded (age, weight, ASA physical status,surgical procedure) as well as blood loss and blood and fluid administered as well as drugs,significant intraoperative events, and the timing of events as they evolve. All data will be entered on a Partners password protected computer. Initially the patient's medical record number which links us to the electronic anesthesia record will be recorded as this allows us to download the data. Patient names will not be downloaded. Once the data set is completed,analyzed and locked, the medical record number will be removed so that no identifiers will remain. The data will not be shared with any other institution. Only deidentified data will remain on the final data base

Conditions

Children Receiving General Anesthesia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

children undergoing general anesthesia

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

cardiac monitor

Intervention Type: DEVICE

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

Interventions

cardiac monitor

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All children presenting to our operating rooms for general anesthesia

Exclusion Criteria

• Cardiac surgery, open chest procedures

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Charles Cote

Director of Clinical Research, Divisionof Pediatric Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25130947 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24916144 (View on PubMed)

Other Identifiers

2010-P-002709/1; MGH

Identifier Type: -

Identifier Source: org_study_id