NCT03455413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

February 27, 2018

Last Update Submit

November 23, 2020

Conditions

Invasive VentilationElective Surgery

Keywords

electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • Silent spacies

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

    24 hours

Secondary Outcomes (2)

  • Ventilation distribution

    24 hours

  • Effect of interventions on ventilatory parameters

    24 hours

Interventions

Swisstom BB2 EIT deviceDEVICE

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

Eligibility Criteria

Age2 Hours - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates and infants undergoing elective/semi-elective surgery

You may qualify if:

  • Written informed consent from a parent of legal guardian
  • Infant undergoing elective or semi-elective surgery
  • Postoperative admission to PICU expected

You may not qualify if:

  • Need for respiratory support prior to surgery
  • Thoracic surgery
  • Body weight \< 1500g or \> 10 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Study Officials

  • Merja Kallio, MD, PhD

    Oulu University Hospital and PEDEGO research group, University of Oulu

    STUDY DIRECTOR

  • Marika Rahtu

    Oulu University Hospital and PEDEGO research group, University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 6, 2018

Study Start

August 3, 2018

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)