Premature Birth, Respiratory Distress Syndrome, Newborn, Respiratory Failure
Conditions
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).
Interventions
OTHERvolume guarantee
volume guarantee assist-control mechanical ventilation
OTHERpressure-controlled
pressure-controlled assist-control mechanical ventilation
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective crossover study
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 27 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| StO2 | 6 hours | Cerebral oxygenation measured using near-infrared spectroscopy \[percent\] |
| 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 \[L/min/m2\] |
| 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 |
Countries
Poland
Outcome results
None listed