Skip to main content
Clinical Trials/NCT03455400
NCT03455400
Completed
Not Applicable

Ventilation Distribution Observed With Electrical Impedance Tomography (EIT) During Spontaneous Breathing in Healthy Newborn Infants

University of Oulu1 site in 1 country20 target enrollmentMarch 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spontaneous Breathing
Sponsor
University of Oulu
Enrollment
20
Locations
1
Primary Endpoint
Right-to-left ventilation distribution
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support in neonatal and pediatric intensive care. In this observational study basic EIT parameters will be measured on 20 healthy newborn infants during spontaneous breathing and assess the effect of position changes in ventilation distribution.

Detailed Description

NEO SensorBelts will be used to observe ventilation distribution in healthy newborn infants during quiet spontaneous breathing. Child's position will be changed 5 times every 10 minutes in a random order. Positions observed will be: left lateral, right lateral, supine, prone face to left, prone face to right and supine with the bed tilted 30 degrees. Total duration for the recording will be 1 hour.

Registry
clinicaltrials.gov
Start Date
March 5, 2018
End Date
August 31, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Written informed consent from a parent or legal guardian
  • Gestational age 37+0 - 42+0 weeks
  • Uneventful follow-up in maternity ward

Exclusion Criteria

  • Respiratory distress
  • Admission to NICU
  • Thorax skin lesions
  • Prior participation in this study

Outcomes

Primary Outcomes

Right-to-left ventilation distribution

Time Frame: 1 hour

Changes in right-to-left ventilation distribution following position changes will be calculated

Anteroposterior ventilation distribution

Time Frame: 1 hour

The ventral-to-dorsal center of ventilation will be calculated as described in (Frerichs et al., Acta AnaesthesiolScand. 1998; 42:721-726) as a value between 0 and 100%, higher values indicating a more dorsal distribution of ventilation.

Study Sites (1)

Loading locations...

Similar Trials