N/A
N=95
Heart Rate Variability in Trauma Patients
Trauma
Bottom Line
View on ClinicalTrials.gov: NCT00795535 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Base Deficit </= -6 — 12 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Base Deficit </= -6 |
12 | — |
| PRIMARY Serious Injury |
36 | — |
| PRIMARY Life Saving Intervention in the Operating Room. |
10 | — |
| PRIMARY SDNN: Standard Deviation of the Normal-to-normal R-R Interval |
42 | < 0.15 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center
- An additional study population will be comprised of patients already admitted to the trauma center for presumptive Traumtaic Brain Injury
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00795535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.