General AnesthesiaNCT05275309
Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions
A study testing Exploration of optimal PEEP in supine and prone position in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Exploration of optimal PEEP in supine and prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2022to 30 Dec 2022
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children <= years of age who are scheduled for surgery in the prone position under general anesthesia
Who cannot join
- Respiratory distress, bronchopulmonary dysplasia
- Pneumothorax
- Increased intracranial pressure
- History of airway surgery
- Cervical or thoracic surgery
- Pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions.
- Conditions
- General Anesthesia
- Being tested
- Exploration of optimal PEEP in supine and prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploration of optimal PEEP in supine and prone positionOther
- General anesthesia is done in routine manner
- A sensor for electrical impedance tomography (EIT) is applied around the patient's chest.
- In supine position, lung recruitment maneuver is done, followed by decremental PEEP trial. Based on EIT parameter, optimal PEEP which induces minimal overdistension and collapse of lungs is determined.
- One hour after prone position, optimal PEEP is determined again.
| Study group | Role | What they receive |
|---|---|---|
| Children <= 1 years old | Experimental | Pediatric patients <= 1 years old of age scheduled for surgery in the prone position Receives: Other: Exploration of optimal PEEP in supine and prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PEEP level at spine position
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position
Measured: 10 minutes after intubation (supine)
Optimal PEEP level at prone position
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position
Measured: 1 hour after prone positioning (prone)
Secondary outcomes (4)
Dynamic compliance measured using Electrical impedance tomography
ventilation/pressure (ml/cmH2O)
Measured: until 1 hour after prone positioning
regional ventilation delay measured using Electrical impedance tomography
ventilation time delay during one breath (no unit)
Measured: until 1 hour after prone positioning
pulmonary opening pressure measured using Electrical impedance tomography
alveoli opening pressure (cmH2O)
Measured: until 1 hour after prone positioning
atelectasis/overdistension ratio measured using Electrical impedance tomography
The degree comparing atelectasis and overdistension (no unit)
Measured: until 1 hour after prone positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start14 Mar 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275309
- Sponsor's protocol ID
- H2111-072-1272
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions
- ClinicalTrials.gov ID
- NCT05275309
- Acronym / sponsor ID
- H2111-072-1272
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Mar 2022 (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.
The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children <= 1 years old | Experimental | Other: Exploration of optimal PEEP in supine and prone positionPediatric patients <= 1 years old of age scheduled for surgery in the prone position |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children <= years of age who are scheduled for surgery in the prone position under general anesthesia
Key exclusion criteria (6 listed)
- Respiratory distress, bronchopulmonary dysplasia
- Pneumothorax
- Increased intracranial pressure
- History of airway surgery
- Cervical or thoracic surgery
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 |
|---|---|---|
| Exploration of optimal PEEP in supine and prone position1. General anesthesia is done in routine manner 2. A sensor for electrical impedance tomography (EIT) is applied around the patient's chest. 3. In supine position, lung recruitment maneuver is done, followed by decremental PEEP trial. Based on EIT parameter, optimal PEEP which induces minimal overdistension and collapse of lungs is determined. 4. One hour after prone position, optimal PEEP is determined again. | Other | Children <= 1 years old |
Primary outcome
Optimal PEEP level at spine position
Time frame: 10 minutes after intubation (supine)
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position
Optimal PEEP level at prone position
Time frame: 1 hour after prone positioning (prone)
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position
4 secondary outcomes
Dynamic compliance measured using Electrical impedance tomography
Time frame: until 1 hour after prone positioning
regional ventilation delay measured using Electrical impedance tomography
Time frame: until 1 hour after prone positioning
pulmonary opening pressure measured using Electrical impedance tomography
Time frame: until 1 hour after prone positioning
atelectasis/overdistension ratio measured using Electrical impedance tomography
Time frame: until 1 hour after prone positioning
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 20 Jan 2023.
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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.
Hee-Soo Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exploration of optimal PEEP in supine and prone position in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 6 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 20 Jan 2023. 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 South Korea. 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?
Optimal PEEP level at spine position (time frame: 10 minutes after intubation (supine)). The study lists 2 primary outcomes in all. 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 20 Jan 2023.