Ventilation Therapy; ComplicationsNCT05726877
Optimal PEEP in Pediatric Patients Under 17 Years of Age.
A study testing ventilation strategy in people with Ventilation Therapy; Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- ventilation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2022to 31 Aug 2024
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who are scheduled to undergo general anesthesia in the prone position
- patients who are in age under 17 years
Who cannot join
- had cyanosis or chronic respiratory failure
- had respiratory distress syndrome or bronchopulmonary dysplasia
- had laryngotracheal diseases
- had pulmonary hypertension
- receiving oxygen therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hee-Soo Kim, M.D.,Ph.D., 02-2072-3664, dami0605@snu.ac.kr
About this study
Official title: Determination of Optimal Positive End-expiratory Pressure in Prone Position During General Anesthesia Using Electrical Impedance Tomography in Pediatric Patient Under 17 Years of Age
This study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- ventilation strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation strategyOther
Titrating positive end-expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All patients will be enrolled in the same arm. Receives: Other: ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal positive end-expiratory pressure (PEEP)
result of decremental PEEP trial
Measured: 10 minutes after intubation
Optimal positive end-expiratory pressure (PEEP)
result of decremental PEEP trial
Measured: 60 minutes after prone positioning
Secondary outcomes (21)
Impedance tidal variation
respiratory parameters measured by Electrical Impedance Tomography (EIT) device
Measured: 10 minutes after intubation
Impedance tidal variation
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
regional respiratory system compliance
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
regional respiratory system compliance
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
overdistension or atelectasis
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
overdistension or atelectasis
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
end-expiratory lung volume
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
end-expiratory lung volume
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
end-expiratory lung impedance
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
end-expiratory lung impedance
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
regional ventilation delay
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
regional ventilation delay
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
center of ventilation
respiratory parameters measured by EIT device
Measured: 10 minutes after intubation
center of ventilation
respiratory parameters measured by EIT device
Measured: 60 minutes after prone positioning
vital signs
blood pressure (mmHg)
Measured: 10 minutes after intubation
vital signs
blood pressure (mmHg)
Measured: 60 minutes after prone positioning
vital signs
oxygen saturation (%)
Measured: 10 minutes after intubation
vital signs
oxygen saturation (%)
Measured: 60 minutes after prone positioning
vital signs
heart rate (BPM)
Measured: 10 minutes after intubation
vital signs
heart rate (BPM)
Measured: 60 minutes after prone positioning
arterial blood gas analysis, if patients has arterial catheter
oxygen and cardon dioxide tension
Measured: 10 minutes after intubation & 60 minutes 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 posted14 Feb 2023
- Study start17 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Soo Kim, MD.Ph.D., Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726877
- Sponsor's protocol ID
- 2208-091-1351
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- 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 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Positive End-expiratory Pressure in Prone Position During General Anesthesia Using Electrical Impedance Tomography in Pediatric Patient Under 17 Years of Age
- ClinicalTrials.gov ID
- NCT05726877
- Acronym / sponsor ID
- 2208-091-1351
- Conditions
- Ventilation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 14 Feb 2023 (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 study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: ventilation strategyAll patients will be enrolled in the same arm. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients who are scheduled to undergo general anesthesia in the prone position
- patients who are in age under 17 years
Key exclusion criteria (5 listed)
- had cyanosis or chronic respiratory failure
- had respiratory distress syndrome or bronchopulmonary dysplasia
- had laryngotracheal diseases
- had pulmonary hypertension
- receiving oxygen therapy
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 |
|---|---|---|
| ventilation strategyTitrating positive end-expiratory pressure | Other | Experimental arm |
Primary outcome
Optimal positive end-expiratory pressure (PEEP)
Time frame: 10 minutes after intubation
result of decremental PEEP trial
Optimal positive end-expiratory pressure (PEEP)
Time frame: 60 minutes after prone positioning
result of decremental PEEP trial
21 secondary outcomes
Impedance tidal variation
Time frame: 10 minutes after intubation
Impedance tidal variation
Time frame: 60 minutes after prone positioning
regional respiratory system compliance
Time frame: 60 minutes after prone positioning
regional respiratory system compliance
Time frame: 10 minutes after intubation
overdistension or atelectasis
Time frame: 10 minutes after intubation
overdistension or atelectasis
Time frame: 60 minutes after prone positioning
end-expiratory lung volume
Time frame: 10 minutes after intubation
end-expiratory lung volume
Time frame: 60 minutes after prone positioning
end-expiratory lung impedance
Time frame: 10 minutes after intubation
end-expiratory lung impedance
Time frame: 60 minutes after prone positioning
regional ventilation delay
Time frame: 10 minutes after intubation
regional ventilation delay
Time frame: 60 minutes after prone positioning
center of ventilation
Time frame: 10 minutes after intubation
center of ventilation
Time frame: 60 minutes after prone positioning
vital signs
Time frame: 10 minutes after intubation
vital signs
Time frame: 60 minutes after prone positioning
vital signs
Time frame: 10 minutes after intubation
vital signs
Time frame: 60 minutes after prone positioning
vital signs
Time frame: 10 minutes after intubation
vital signs
Time frame: 60 minutes after prone positioning
arterial blood gas analysis, if patients has arterial catheter
Time frame: 10 minutes after intubation & 60 minutes after prone positioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- 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.
Hee-Soo Kim, MD.Ph.D. study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation strategy in people with Ventilation Therapy; Complications, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Soo Kim, M.D., Ph.D. (02-2072-3664, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal positive end-expiratory pressure (PEEP) (time frame: 10 minutes after intubation). 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 14 Feb 2023.