Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

May 19, 2020 updated by: Poznan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznań, Poland, 60-535
        • Department of Neonatology at Poznań University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mechanical ventilation
Preterm infants on mechanical ventilation
Other: volume guarantee
volume guarantee assist-control mechanical ventilation
Other: pressure-controlled
pressure-controlled assist-control mechanical ventilation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Study Chair: Tomasz Szczapa, MD, PhD, Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 388/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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