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Autonomic Challenges From Mild Hypovolemia and Mechanical Ventilation

NCT03244891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-10-14

No results posted yet for this study

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 frequently used to describe the HRV.

Conditions

  • Autonomic Nervous System Imbalance
  • Hypovolemia
  • Positive-Pressure Respiration

Interventions

OTHER

Increase of central volume

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

OTHER

Ventilation mode

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

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244891 on ClinicalTrials.gov