CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Increase of central volume +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03244891
NCT03244891N/ACompleted

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

ASST Fatebenefratelli Sacco·interventional·Posted Aug 10, 2017·Updated Oct 14, 2019

In Brief

A clinical study evaluating Increase of central volume and Ventilation mode for Autonomic Nervous System Imbalance and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 10, 2017
Enrollment StartJun 15, 2019
Primary CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

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