Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391634
• Other study ID #: 388/16
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2020
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 27 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Syndrome

Intervention

Other:
• volume guarantee
volume guarantee assist-control mechanical ventilation
• pressure-controlled
pressure-controlled assist-control mechanical ventilation

Locations

Country	Name	City	State
Poland	Department of Neonatology at Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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