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NCT03455413 Clinical Trial

Quality of Perioperative Invasive Ventilation in PICU

Elective Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03455413
Other study ID # EETTMK:36/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2018
Est. completion date October 6, 2020

Study information
Verified date November 2020
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 6, 2020
Est. primary completion date October 6, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Swisstom BB2 EIT device
Swisstom BB2 EIT device and NeoSensor Belts will be used to assess lung aeration, ventilation distribution and strech during invasive ventilation in perioperative care.

Locations
Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Silent spacies Amount of silent spaces observed in different phases of treatment in comparison to baseline 24 hours
Secondary Ventilation distribution Changes from baseline in ventilation distribution will be assessed in different phases of treatment 24 hours
Secondary Effect of interventions on ventilatory parameters Relationship between intubation/invasive ventilation/extubation/spontaneous breathing and EIT findings 24 hours
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