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NCT01499615 · ClinicalTrials.gov registry record
A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 402
- Enrollment target
NCT01499615: Completed study, sponsored by Massachusetts General Hospital.
NCT01499615 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 402 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499615 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 402 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE cardiac monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-01 |
What the finished NCT01499615 record still lists
NCT01499615 is an observational study that tracks outcomes without assigning an intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which cardiac monitor is the first listed.
NCT01499615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499615 about?
NCT01499615 is a clinical study titled "A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia". 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 ch...
What is the current status of trial NCT01499615?
This trial is currently completed. The enrollment target is 402 participants. The study started on 2012-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01499615?
The interventions under investigation include: cardiac monitor (DEVICE).
Who is sponsoring clinical trial NCT01499615?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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