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Completed

NCT Number: NCT01966198

Estimation of Autonomic Nervous System Modulation by Pulse Plethysmographic Analysis

Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic nervous system state index (ANSSi).

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Key information

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera "Luigi Sacco" - Polo Universitario - University of Milan

Milan, 20157, Italy

About this study

It has been supposed that indexes derived from pulse plethysmographic analysis -the autonomic nervous system state (ANSS) and ANSS index (ANSSi)- may be useful tools to measure the autonomic nervous system (ANS) activity but, to date, physiologic experimental evidences are lacking.

Traditionally,it is widely accepted that ANS modulation and the baro-reflex control can be non-invasively studied through heart rate variability (HRV) and systolic variability analyses.

The aim of this study is to assess if PPGA-derived indexes are able to detect changes of ANS system modulation directed to heart and vessels.

Changes in position of patients lead to changes in the balance of the ANS. One of the most used manoeuver to stimulate ANS is head-up tilt (HUT). Tilt causes pooling of blood toward lower body and reduces the venous return to the heart. These activation of ANS leads to an increase of heart rate and peripheral vascular resistance aiming to maintain arterial pressure near to the level preceding the challenge (baro-reflex control).

Methods: we study the effects of sympathetic stimulation on ANSS and ANSSi induced with two different tilt at 45 and 90 degrees angles. We compare the ANSS and ANSSi with HRV analysis and baro-reflex control analysis. We plan to study 7 volunteers to detect a difference of 30 (standard deviation of 15) between the mean of ANSS and ANSSi at baseline and during tilt, with a power of 80% and alfa error of 5%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult healthy humans (american society of anesthesiologists class I)
  • age between 25 and 35 years old
  • no assumption of any drug, beverages containing caffeine or alcohol during the previous 24 hours
  • fasting 3 hours before the study protocol

Exclusion criteria

  • american society of anesthesiologists class >1
  • age <25 or >35 years
  • pregnancy
  • accidental discover of non sinus cardiac rhythm or ectopic beats >5%

Treatment and study plan

tilt test

Other

The experiment protocol consists of a sequence of passive postural changes gained with a tilt table, each of them lasting 10 minutes. The sequence consists of: (i) baseline recording in supine position; (ii) tilt at 45 degrees angle; (iii) recovery period in supine position; (iv) tilt at 90 degrees angle and (v) recovery in supine position.

Primary outcomes

  1. to measure the degree of correlation of ANSS and ANSSi with LF/HF and baroreflex sensitivity and their agreement in response to an orthostatic sympathetic load

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2013
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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