AzTrials
AzTrials

Autonomic Nervous System ImbalanceNCT03244891

Autonomic Challenges From Mild Hypovolemia and Mechanical Ventilation

A study testing Increase of central volume and Ventilation mode in people with Autonomic Nervous System Imbalance and Hypovolemia, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Heart Rate Variability (HRV) analysis has been studied in the critically ill patients although it is affected by several uncontrolled variables in the clinical conditions. The aim of this trial is to measure the effects of mildly reduced central volume and cyclic variation of intrathoracic pressure on the variables… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
Increase of central volume and Ventilation mode
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
15 Jun 2019to 30 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy volunteers

Who cannot join

  • history of cardiac, metabolic, respiratory, renal, neurological or hematologic disease of any kind
  • chronically assuming drugs of any kind
  • non sinus cardiac rhythm
  • ectopic beats >5% of all cardiac beats
  • claustrophobia or unable to tolerate noninvasive ventilation via facial mask

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • ASST Fatebenefratelli Sacco, Luigi Sacco Hospital

    Milan, 20157

Other trials in Italy

About this study

Official title: Effects of Low Central Volume and Intermittent Positive Pressure Ventilation on the Heart Rate Variability

Heart Rate Variability (HRV) analysis has been studied in the critically ill patients although it is affected by several uncontrolled variables in the clinical conditions. The aim of this trial is to measure the effects of mildly reduced central volume and cyclic variation of intrathoracic pressure on the variables frequently used to describe the HRV.

Read the detailed description

Twelve healthy volunteers will be studied. Mild hypovolemia will be induced by 12 hours fasting from food and drinks. At 8.30 AM the study protocol will start. The studied subjects will lie calm supine in a ICU bed able to provide passive head up and head down tilt. They will be connected to a Siemens SC9000 monitor showing their ECG waves and to a Nexfin (BMEYE) monitor for continuous noninvasive blood pressure (NBP) assessment. Both waves (ECG and NBP) will be recorded on a laptop PC through analogic/digital input/output converter (PowerLab 8/35, ADinstruments). The studied subjects will undergo to a sequence of (1) spontaneous breathing at 10 degrees head up, (2) spontaneous breathing at 7 degrees head down, (3) noninvasive ventilation at 10 degrees head up, and (4) noninvasive ventilation at 7 degrees head down. The sequence 1-2-3-4 will be randomized. After this four phases, a fluid challenge of ringer acetate 15ml*kg will be intravenously administered and the a sequence 1-2-3-4 will be repeated after a new randomization. Noninvasive ventilation will be provided with a facial mask with ventilatory setting: Psupp 8 cmH2O, PEEP 5 cmH2O, FiO2 0.28. Psupp will be decreased by 2 cmH2O steps if the inspiratory tidal volume will be >10ml*kg. During both spontaneous breathing and noninvasive ventilation the subjects will breathe following a metronome at 18bpm.

HRV analysis will be conducted following the recommendation of the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology (see reference).

Furthermore, the healthy volunteers will be studied by trans-thoracic ultrasound assessment with a Philips EPIQ7 sonographer, during each study phase.

Being tested
Increase of central volume, Ventilation mode
Medical subject headings
Hypovolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increase of central volumeOther

    Mild hypovolemia will be induced in healthy volunteers by 12 hours fasting. Three conditions will be considered for the analysis, each of them both during spontaneous breathing and positive pressure ventilation:

    1. baseline
    2. after fluid shift induced by passive head down position at 15 degrees
    3. after fluid challenge with Ringer acetate 15ml*kg in head down position

    A total of six steps will be considered for the analysis

  • Ventilation modeOther

    Each previous step will be done in two respiratory conditions:

    1. spontaneous breathing
    2. noninvasive ventilation via facial mask in pressure support mode at 8 cmH2O above positive end expiratory pressure of 5 cmH2O, inspiratory fraction of oxygen of 0.25 In both conditions respiratory rate will be set at 18 breaths per min following a metronome
Study groups in NCT03244891
Study groupRoleWhat they receive
Studied subjectsExperimentalEach subject will be studied during two sequential phases: 1. before fluid challenge 2. after fluid challenge During each phase, the subjects will be studied at: 1. baseline - spontaneously breathing 2. head down position - spontaneously breathing 3. baseline - positive pressure ventilation 4. head down position - positive pressure ventilation The sequence a-b-c-d will be randomized for each subject and for each phase
Receives: Other: Increase of central volume; Other: Ventilation mode

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of increasing central blood volume on heart rate variability

    The studied subjects will undergo to increase of central blood volume in two steps:

    1. passive head down tilt at -7 degrees
    2. intravenous infusion of ringer acetate of 15ml*kg body weight

    Measured: 10 mins each step

  2. Effect of cyclic intrathoracic pressure oscillations on heart rate variability

    The studied subject will undergo to two ventilatory modes:

    1. spontaneous breathing at 18 breaths per min
    2. positive pressure ventilation via face mask

    Measured: 10 min each step

Secondary outcomes (1)

  1. Effects of increasing central blood volume and of cyclic intrathoracic pressure oscillations on echographic cardiac function variables

    At each step cardiac functionality assessment will be done by transthoracic echocardiography

    Measured: 10 mins each step

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start15 Jun 2019
  3. Primary completion30 Jul 2019
  4. Study completion30 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244891
Sponsor's protocol ID
HRV2017_Healthy
Status last verified
Oct 2019
First submitted
5 Aug 2017
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guyton JE, Arthur C. The Autonomic Nervous System and The Adrenal Medulla, in Textbook of Medical Physiology, 12th ed., Saunders Elsevier, Ed. Philadelphia, 2011, pp. 738-739

  • Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045.

    PubMed 6166045

  • Ferrario M, Moissl U, Garzotto F, Cruz DN, Tetta C, Signorini MG, Ronco C, Grassmann A, Cerutti S, Guzzetti S. The forgotten role of central volume in low frequency oscillations of heart rate variability. PLoS One. 2015 Mar 20;10(3):e0120167. doi: 10.1371/journal.pone.0120167. eCollection 2015.

    PubMed 25793464

  • Galletly DC, Larsen PD. Relationship between cardioventilatory coupling and respiratory sinus arrhythmia. Br J Anaesth. 1998 Feb;80(2):164-8. doi: 10.1093/bja/80.2.164.

    PubMed 9602579

  • Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.

    PubMed 16540963

  • 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.

    PubMed 8598068

Questions about this trial

What is this clinical trial studying?

A study testing Increase of central volume and Ventilation mode in people with Autonomic Nervous System Imbalance and Hypovolemia, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of increasing central blood volume on heart rate variability (time frame: 10 mins each step). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244891, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in