Trauma Heart to Arm Time (THAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT01210417
First received: September 27, 2010
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Intervention
Trauma
Hypovolemia
Hemorrhage
Other: Non invasive monitoring

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Niguarda Hospital:

Enrollment: 100
Study Start Date: September 2010
Study Completion Date: May 2011
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01210417

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

No publications provided

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT01210417     History of Changes
Other Study ID Numbers: 179_06/2010
Study First Received: September 27, 2010
Last Updated: February 20, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Niguarda Hospital:
Trauma
Hypovolemia
Hemorrhage
Out of hospital trauma

Additional relevant MeSH terms:
Hemorrhage
Wounds and Injuries
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014