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Clinical Trials/NCT04391634
NCT04391634
Completed
Not Applicable

Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome

Poznan University of Medical Sciences1 site in 1 country25 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Newborn
Sponsor
Poznan University of Medical Sciences
Enrollment
25
Locations
1
Primary Endpoint
Stroke volume variation (SVV)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.

Detailed Description

Prospective, cross-over trial enrolling neonates \<28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
May 30, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Poznan University of Medical Sciences
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • premature infants born \<28 weeks of gestation
  • respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
  • stable condition with pH (acidity of blood)\> 7.2 and pCO2 (carbon dioxide partial pressure) \<60 mmHg in the blood gas analysis
  • no identified genetic syndromes and serious congenital malformations

Exclusion Criteria

  • lack of written consent of patients' parents

Outcomes

Primary Outcomes

Stroke volume variation (SVV)

Time Frame: 6 hours

Stroke volume variation (SVV) monitored with electrical cardiometry \[percent\]

Index of contractility

Time Frame: 6 hours

Index of contractility (ICON) monitored with electrical cardiometry

Stroke volume

Time Frame: 6 hours

Stroke volume (SV) monitored with electrical cardiometry \[ml\]

Cardiac output

Time Frame: 6 hours

Cardiac output (CO) monitored with electrical cardiometry \[L/min\]

Stroke index

Time Frame: 6 hours

Stroke index (SI) monitored with electrical cardiometry \[ml/m2\]

Cardiac index

Time Frame: 6 hours

Cardiac index (CI) monitored with electrical cardiometry \[L/min/m2\]

StO2

Time Frame: 6 hours

Cerebral oxygenation measured using near-infrared spectroscopy \[percent\]

Study Sites (1)

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