A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
Public ClinicalTrials.gov record NCT01499615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01499615
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 402 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Hour to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- Dec 31, 2013
- Completion
- Dec 31, 2013
- Last update posted
- Apr 8, 2015
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital | Boston | Massachusetts | 02114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01499615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2015 · Synced Sep 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01499615 live on ClinicalTrials.gov.