Trauma Heart to Arm Time (THAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01210417
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Niguarda Hospital

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
Trauma Hypovolemia Hemorrhage Other: Non invasive monitoring

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Group/Cohort 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All trauma victims enrolled by our Helicopter Emergency Medical System (HEMS)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01210417

A.R.E.U. - A.A.T. 118 Milano
Milano, Italy, 20100
Sponsors and Collaborators
Niguarda Hospital

Responsible Party: Niguarda Hospital Identifier: NCT01210417     History of Changes
Other Study ID Numbers: 179_06/2010
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Niguarda Hospital:
Out of hospital trauma

Additional relevant MeSH terms:
Wounds and Injuries
Pathologic Processes