Invasive VentilationNCT03455413
Quality of Perioperative Invasive Ventilation in PICU
An observational study of Invasive Ventilation and Elective Surgery, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 2 hours to 1 year
- Conditions the study is for
- Invasive Ventilation, Elective Surgery
- What is being tested?
- Swisstom BB2 EIT device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 3 Aug 2018to 6 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 hours to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants undergoing elective/semi-elective surgery
Who may be able to join
- 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
Who cannot join
- Need for respiratory support prior to surgery
- Thoracic surgery
- Body weight < 1500g or > 10 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Impedance Tomography (EIT) in Assessing the 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.
Read the detailed 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.
- Conditions
- Invasive Ventilation, Elective Surgery
- Being tested
- Swisstom BB2 EIT device
- Keywords
- electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Silent spacies
Amount of silent spaces observed in different phases of treatment in comparison to baseline
Measured: 24 hours
Secondary outcomes (2)
Ventilation distribution
Changes from baseline in ventilation distribution will be assessed in different phases of treatment
Measured: 24 hours
Effect of interventions on ventilatory parameters
Relationship between intubation/invasive ventilation/extubation/spontaneous breathing and EIT findings
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start3 Aug 2018
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merja Kallio, MD, PhD, Study director, Oulu University Hospital and PEDEGO research group, University of OuluMarika Rahtu, Principal investigator, Oulu University Hospital and PEDEGO research group, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455413
- Sponsor's protocol ID
- EETTMK:36/2017
- Status last verified
- Nov 2020
- First submitted
- 27 Feb 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography (EIT) in Assessing the Quality of Perioperative Invasive Ventilation in PICU
- ClinicalTrials.gov ID
- NCT03455413
- Acronym / sponsor ID
- EETTMK:36/2017
- Conditions
- Invasive Ventilation, Elective Surgery
- Keywords
- electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 hours to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants undergoing elective/semi-elective surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Need for respiratory support prior to surgery
- Thoracic surgery
- Body weight < 1500g or > 10 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swisstom BB2 EIT deviceSwisstom BB2 EIT device and NeoSensor Belts will be used to assess lung aeration, ventilation distribution and strech during invasive ventilation in perioperative care. | Device | – |
Primary outcome
Silent spacies
Time frame: 24 hours
Amount of silent spaces observed in different phases of treatment in comparison to baseline
2 secondary outcomes
Ventilation distribution
Time frame: 24 hours
Effect of interventions on ventilatory parameters
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merja Kallio, MD, PhD study director
Oulu University Hospital and PEDEGO research group, University of Oulu
Marika Rahtu principal investigator
Oulu University Hospital and PEDEGO research group, University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Ventilation and Elective Surgery, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silent spacies (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.