Trauma
Conditions
Keywords
Injury
Brief 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.
Detailed description
The eligible study population will be comprised of patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center or who are already admitted to the trauma center for presumptive traumatic brain injury. In addition to the EKG, trauma patients may also be connected to either an non-invasive NIR Monitor, which provides real-time information about perfusion status and/or a bispectral EEG monitor, which provides real-time information about brain metabolic activity.
Interventions
None listed
Sponsors
University of Miami
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Base Deficit </= -6 | Upon arrival to the hospital | 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. |
| Serious Injury | Upon arrival to the hospital | A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect. |
| Life Saving Intervention in the Operating Room. | Upon arrival to the hospital | A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect. |
| SDNN: Standard Deviation of the Normal-to-normal R-R Interval | Upon arrival to the hospital | A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trauma Patients Patients transported to the trauma center by helicopter | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incomplete data and technical problems | 20 |
Baseline characteristics
| Characteristic | Trauma Patients |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 20 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
Base Deficit </= -6
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.
Time frame: Upon arrival to the hospital
Population: 75 patients with complete HRV and trauma registry data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trauma Patients | Base Deficit </= -6 | 12 participants |
Primary
Life Saving Intervention in the Operating Room.
A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.
Time frame: Upon arrival to the hospital
Population: 75 patients with complete HRV and trauma registry data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trauma Patients | Life Saving Intervention in the Operating Room. | 10 participants |
Primary
SDNN: Standard Deviation of the Normal-to-normal R-R Interval
A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.
Time frame: Upon arrival to the hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trauma Patients | SDNN: Standard Deviation of the Normal-to-normal R-R Interval | 42 milliseconds (ms) | Standard Deviation 31 |
Comparison: Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.p-value: <0.15Wilcoxon (Mann-Whitney)
Primary
Serious Injury
A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.
Time frame: Upon arrival to the hospital
Population: 75 patients with complete HRV and trauma registry data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trauma Patients | Serious Injury | 36 participants |