Estimation of Autonomic Nervous System Modulation by Pulse Plethysmographic Analysis

NCT01966198 | Completed

• 1 other identifier: 31082013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Autonomic Nervous System Modulation

Keywords

pulse plethysmography, autonomic nervous system, heart rate variability, baro-reflex

Outcome Measures

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

  1 week

Study Arms (1)

all patients

EXPERIMENTAL

tilt

Other: Tilt test

Interventions

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.

all patients

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

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

Milan, 20157, Italy

Location

Related Publications (9)

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.

  PMID: 21051493 BACKGROUND

• Hamunen K, Kontinen V, Hakala E, Talke P, Paloheimo M, Kalso E. Effect of pain on autonomic nervous system indices derived from photoplethysmography in healthy volunteers. Br J Anaesth. 2012 May;108(5):838-44. doi: 10.1093/bja/aes001. Epub 2012 Feb 26.

  PMID: 22369767 BACKGROUND

• Paloheimo MP, Sahanne S, Uutela KH. Autonomic nervous system state: the effect of general anaesthesia and bilateral tonsillectomy after unilateral infiltration of lidocaine. Br J Anaesth. 2010 May;104(5):587-95. doi: 10.1093/bja/aeq065. Epub 2010 Mar 30.

  PMID: 20354006 BACKGROUND

• Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.

  PMID: 7923668 BACKGROUND

• Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

  PMID: 2874900 BACKGROUND

• Cooke WH, Hoag JB, Crossman AA, Kuusela TA, Tahvanainen KU, Eckberg DL. Human responses to upright tilt: a window on central autonomic integration. J Physiol. 1999 Jun 1;517 ( Pt 2)(Pt 2):617-28. doi: 10.1111/j.1469-7793.1999.0617t.x.

  PMID: 10332107 BACKGROUND

• Kamiya A, Iwase S, Sugiyama Y, Mano T, Sudoh M. Vasomotor sympathetic nerve activity in men during bed rest and on orthostasis after bed rest. Aviat Space Environ Med. 2000 Feb;71(2):142-9.

  PMID: 10685588 BACKGROUND

• Colombo R, Marchi A, Borghi B, Fossali T, Rech R, Castelli A, Corona A, Guzzetti S, Raimondi F. Pulse Photoplethysmographic Analysis Estimates the Sympathetic Activity Directed to Heart and Vessels. Anesthesiology. 2015 Aug;123(2):336-45. doi: 10.1097/ALN.0000000000000712.

  PMID: 26035252 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 12, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

IT (1)