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CompletedNCT01210417THATUpdated Feb 22, 2012

Trauma Heart to Arm Time

An observational study in Trauma, Hypovolemia and Hemorrhage, sponsored by Niguarda Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Niguarda Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Trauma
  • Hypovolemia
  • Hemorrhage

Keywords

  • Trauma
  • Hypovolemia
  • Hemorrhage
  • Out of hospital trauma
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 893 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • Trauma victims

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

    Other: Non invasive monitoring

Interventions

  • OtherNon invasive monitoring

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

06

Study locations

1 site
  • A.R.E.U. - A.A.T. 118 Milano
    Milano, 20100, Italy
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01210417
Lead sponsor
Niguarda Hospital
Responsible party
Sponsor
First posted
Sep 28, 2010
Start date
Sep 2010
Completion
May 2011
Last update
Feb 22, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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