Trial Outcomes & Findings for Heart Rate Variability in Trauma Patients (NCT NCT00795535)
NCT ID: NCT00795535
Last Updated: 2015-02-09
Results Overview
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.
COMPLETED
95 participants
Upon arrival to the hospital
2015-02-09
Participant Flow
Participant milestones
| Measure |
Trauma Patients
Patients transported to the trauma center by helicopter
|
|---|---|
|
Overall Study
STARTED
|
95
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Trauma Patients
Patients transported to the trauma center by helicopter
|
|---|---|
|
Overall Study
incomplete data and technical problems
|
20
|
Baseline Characteristics
Heart Rate Variability in Trauma Patients
Baseline characteristics by cohort
| Measure |
Trauma Patients
n=75 Participants
Patients transported to the trauma center by helicopter
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Upon arrival to the hospitalPopulation: 75 patients with complete HRV and trauma registry data
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.
Outcome measures
| Measure |
Trauma Patients
n=75 Participants
Patients transported to the trauma center by helicopter
|
|---|---|
|
Base Deficit </= -6
|
12 participants
|
PRIMARY outcome
Timeframe: Upon arrival to the hospitalPopulation: 75 patients with complete HRV and trauma registry data
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.
Outcome measures
| Measure |
Trauma Patients
n=75 Participants
Patients transported to the trauma center by helicopter
|
|---|---|
|
Serious Injury
|
36 participants
|
PRIMARY outcome
Timeframe: Upon arrival to the hospitalPopulation: 75 patients with complete HRV and trauma registry data
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.
Outcome measures
| Measure |
Trauma Patients
n=75 Participants
Patients transported to the trauma center by helicopter
|
|---|---|
|
Life Saving Intervention in the Operating Room.
|
10 participants
|
PRIMARY outcome
Timeframe: Upon arrival to the hospitalA 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.
Outcome measures
| Measure |
Trauma Patients
n=75 Participants
Patients transported to the trauma center by helicopter
|
|---|---|
|
SDNN: Standard Deviation of the Normal-to-normal R-R Interval
|
42 milliseconds (ms)
Standard Deviation 31
|
Adverse Events
Trauma Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Proctor, PhD, Professor of Surgery
University of Miami
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place