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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Elective Surgery
• Invasive Ventilation

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