NCT01210417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

First QC Date

September 27, 2010

Last Update Submit

February 20, 2012

Conditions

Keywords

TraumaHypovolemiaHemorrhageOut of hospital trauma

Study Arms (1)

Trauma victims

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

Other: Non invasive monitoring

Interventions

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

Trauma victims

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.R.E.U. - A.A.T. 118 Milano

Milan, 20100, Italy

Location

MeSH Terms

Conditions

Wounds and InjuriesHypovolemiaHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

September 1, 2010

Study Completion

May 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations