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Completed

NCT Number: NCT03455413

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.

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Key information

Conditions

Invasive Ventilation Elective Surgery

Age range

2 hour–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swisstom BB2 EIT device

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.

Primary outcomes

  1. Silent spacies

    Time frame: 24 hours

    Amount of silent spaces observed in different phases of treatment in comparison to baseline

Secondary outcomes

  1. Ventilation distribution

    Time frame: 24 hours

    Changes from baseline in ventilation distribution will be assessed in different phases of treatment

  2. Effect of interventions on ventilatory parameters

    Time frame: 24 hours

    Relationship between intubation/invasive ventilation/extubation/spontaneous breathing and EIT findings

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2018
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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