Trauma Heart to Arm Time (THAT)

February 20, 2012 updated by: Niguarda Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20100
        • A.R.E.U. - A.A.T. 118 Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 179_06/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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