Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

Not Applicable

Completed

• Conditions: Respiratory Failure; Respiratory Distress Syndrome, Newborn; Premature Birth
• Interventions: Other: volume guarantee; Other: pressure-controlled

• Registration Number: NCT04391634
• Lead Sponsor: Poznan University of Medical Sciences

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).

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-18
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mechanical ventilation	pressure-controlled	Preterm infants on mechanical ventilation
Mechanical ventilation	volume guarantee	Preterm infants on mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Stroke volume variation (SVV)	6 hours	Stroke volume variation (SVV) monitored with electrical cardiometry \[percent\]
Index of contractility	6 hours	Index of contractility (ICON) monitored with electrical cardiometry
Stroke volume	6 hours	Stroke volume (SV) monitored with electrical cardiometry \[ml\]
Cardiac output	6 hours	Cardiac output (CO) monitored with electrical cardiometry \[L/min\]
Stroke index	6 hours	Stroke index (SI) monitored with electrical cardiometry \[ml/m2\]
Cardiac index	6 hours	Cardiac index (CI) monitored with electrical cardiometry \[L/min/m2\]
StO2	6 hours	Cerebral oxygenation measured using near-infrared spectroscopy \[percent\]

Trial Locations

Locations (1)

Department of Neonatology at Poznań University of Medical Sciences; 🇵🇱 Poznań, Poland