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NCT00795535 · ClinicalTrials.gov registry record
Heart Rate Variability in Trauma Patients
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 95
- Enrollment target
NCT00795535: Completed study, sponsored by University of Miami.
NCT00795535 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 95 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00795535 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG will be prospectively measured in trauma patients in two locations: in the prehospital setting (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be derived from the EKG signal, will be correlated with other non-invasive signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), along with other routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be correlated with injury severity and day of discharge. An algorithm will be constructed using multiple linear regression. The hypotheses are: 1. reduced HRV in the field correlates with bad outcome; 2. the specificity and efficiency of HRV as a screening tool can be improved by controlling factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation; 3. an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.
Primary Outcome
Indicator for volume deficit and resuscitation. Number of participants with Base Deficit \</= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit \</= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-12 |
What the finished NCT00795535 record still lists
NCT00795535 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 95 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00795535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00795535 about?
NCT00795535 is a clinical study titled "Heart Rate Variability in Trauma Patients". The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG will be prospectively measured in trauma patients in two locations: in the prehospital setting (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be derived fr...
What is the current status of trial NCT00795535?
This trial is currently completed. The enrollment target is 95 participants. The study started on 2007-05. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT00795535?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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