Quality of Perioperative Invasive Ventilation in PICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-10-06

Brief Summary

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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

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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.

Conditions

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Invasive Ventilation Elective Surgery

Keywords

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electrical impedance tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Hours

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merja Kallio, MD, PhD

Role: STUDY_DIRECTOR

Oulu University Hospital and PEDEGO research group, University of Oulu

Marika Rahtu

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital and PEDEGO research group, University of Oulu

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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EETTMK:36/2017

Identifier Type: -

Identifier Source: org_study_id