Quality of Perioperative Invasive Ventilation in PICU

Electrical Impedance Tomography (EIT) in Assessing the Quality of Perioperative Invasive Ventilation in PICU

This is purely observational study in which quality of invasive ventilation is observed with electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters will be used to assess if protective ventilation strategies are successfully followed during routine care.

Study Overview

• Status: Completed
• Conditions: Elective Surgery; Invasive Ventilation
• Intervention / Treatment: Device: Swisstom BB2 EIT device

Detailed Description

20 neonates and infants undergoing elective surgery and requiring postoperative treatment and follow up in PICU or in pediatric anestesiology clinic, will be included in this prospective observational study. Swisstom BB2-monitor and NeoSensorBelts will be used to monitor their ventilatory care from arrival to the operation room (prior intubation) to postoperative intensive care (until 2 hours after extubation). EIT parameters assessing lung aeration and ventilation distribution will be used to assess the quality of invasive ventilation.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 hours to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants undergoing elective/semi-elective surgery

Description

Inclusion Criteria:

• Written informed consent from a parent of legal guardian
• Infant undergoing elective or semi-elective surgery
• Postoperative admission to PICU expected
• Spontaneous breathing prior to study inclusion

Exclusion Criteria:

• Need for respiratory support prior to surgery
• Thoracic surgery
• Body weight < 1500g or > 10 kg

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Silent spacies	Amount of silent spaces observed in different phases of treatment in comparison to baseline	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation distribution	Changes from baseline in ventilation distribution will be assessed in different phases of treatment	24 hours
Effect of interventions on ventilatory parameters	Relationship between intubation/invasive ventilation/extubation/spontaneous breathing and EIT findings	24 hours

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Study Director: Merja Kallio, MD, PhD, Oulu University Hospital and PEDEGO research group, University of Oulu; Principal Investigator: Marika Rahtu, Oulu University Hospital and PEDEGO research group, University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: electrical impedance tomography
• Other Study ID Numbers: EETTMK:36/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No