Quality of Perioperative Invasive Ventilation in PICU

Completed

• Conditions: Invasive Ventilation; Elective Surgery

• Registration Number: NCT03455413
• Lead Sponsor: University of Oulu

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-06
• Study Start: 2018-08-03
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Silent spacies	24 hours	Amount of silent spaces observed in different phases of treatment in comparison to baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland