THAT: Trauma Heart to Arm Time

Sponsor

Niguarda Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01210417

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the prehospital setting it would be helpful to assess primary changes in central blood volume or preload (venous return, stroke volume, diastolic ventricular volume) that occur during the stability phase following injury when regulatory mechanisms are still functioning.

Obviously in this setting a non invasive bedside beat-to-beat index would be helpful.

Pulse Transit Time (PTT) is the sum of Pre-Ejection Period (PEP), the time interval between the onset of ventricular depolarization and the ventricular ejection, and Vascular Transit Time (VTT), the time it takes for the pulse wave to travel from the aortic valve to the peripheral arteries (Obrist et al. 1979). PEP variations are known to correlate with reductions in central blood volume induced by head-up tilt (Chan et al., 2007b, 2008). The same authors also demonstrated that PTT variations follow closely PEP variations and therefore central blood volume variations (Chan et al., 2007b). Following central blood volume reductions induced by head-up tilting ventricular diastolic filling time increases involving an increase in PEP and PTT. Chan et al. (Chan et al., 2007b) concluded that PTT could have been used to assess early central hypovolemia and suggested that joint analysis of PTT and RR intervals could help in predicting the extent of blood volume loss. The investigators hypothesized that sympathetic drive associated with trauma would act on cardiac contractility through beta activity thus shortening PTT without reducing RR interval to the same extent in healthy hearts. We also hypothesized that progressive hypovolemia would lead to a rising of PTT (augmented diastolic filling time) and a RR interval shortening (relative tachycardia). In this study the investigators propose and index based on the beat-to-beat PTT/RR ratio to assess central hypovolemia in traumatic patients enrolled by our Helicopter Emergency Medical System (HEMS) in a prehospital setting.

Condition or Disease	Intervention/Treatment	Phase
Trauma Hypovolemia Hemorrhage	Other: Non invasive monitoring

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Study Start Date :

Sep 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Trauma victims All prehospital traumatic patients enrolled by our Helicopter Emergency Medical System (HEMS)	Other: Non invasive monitoring Three-lead electrocardiogram (ECG), PPG oxymetry, non-invasive blood pressure (NIBP) are registered

Arm

Intervention/Treatment

Trauma victims

All prehospital traumatic patients enrolled by our Helicopter Emergency Medical System (HEMS)

Other: Non invasive monitoring

Three-lead electrocardiogram (ECG), PPG oxymetry, non-invasive blood pressure (NIBP) are registered

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all trauma victims enrolled by our Helicopter Emergency Medical System (HEMS)

Exclusion Criteria:

need of immediate life-saving manoeuvres as decided by onboard physician following Prehospital Trauma Care (PTC) criteria (CITATION PTC)
Cardiac arrest
presence of preexisting chronic illnesses involving the autonomic nervous system such as hypertension, diabetes and any neurological disease
any preexisting medical therapy including those administered by the emergency medical team as defined in point 1)
presence of supraventricular ectopic beats more than 5% of total recorded beats
absence of sinus rhythm
presence of intraventricular or bundle branch blocks or artificial pacemaker
spinal chord trauma above D2
patient age <18 years
presence of burns not allowing monitoring