Status unknownNCT05726877Updated Feb 14, 2023

Optimal PEEP in Pediatric Patients Under 17 Years of Age.

An interventional study of ventilation strategy in Ventilation Therapy; Complications, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 51
Allocation: Not applicable
Ages: 0 Years to 16 Years
Sex: All

Study 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.

Conditions studied

Ventilation Therapy; Complications

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 0 Years to 16 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

patients who are scheduled to undergo general anesthesia in the prone position
patients who are in age under 17 years

Exclusion criteria

Exclusion Criteria:

had cyanosis or chronic respiratory failure
had respiratory distress syndrome or bronchopulmonary dysplasia
had laryngotracheal diseases
had pulmonary hypertension
receiving oxygen therapy

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 51 participants (estimated)

Study arms

Experimental
Experimental arm
All patients will be enrolled in the same arm.
Other: ventilation strategy

Interventions

Otherventilation strategy
Titrating positive end-expiratory pressure

What researchers measure

Primary outcomes

Optimal positive end-expiratory pressure (PEEP)
result of decremental PEEP trial
Time frame: 10 minutes after intubation
Optimal positive end-expiratory pressure (PEEP)
result of decremental PEEP trial
Time frame: 60 minutes after prone positioning

Secondary outcomes

Impedance tidal variation
respiratory parameters measured by Electrical Impedance Tomography (EIT) device
Time frame: 10 minutes after intubation
Impedance tidal variation
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
regional respiratory system compliance
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
regional respiratory system compliance
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
overdistension or atelectasis
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
overdistension or atelectasis
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
end-expiratory lung volume
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
end-expiratory lung volume
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
end-expiratory lung impedance
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
end-expiratory lung impedance
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
regional ventilation delay
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
regional ventilation delay
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
center of ventilation
respiratory parameters measured by EIT device
Time frame: 10 minutes after intubation
center of ventilation
respiratory parameters measured by EIT device
Time frame: 60 minutes after prone positioning
vital signs
blood pressure (mmHg)
Time frame: 10 minutes after intubation
vital signs
blood pressure (mmHg)
Time frame: 60 minutes after prone positioning
vital signs
oxygen saturation (%)
Time frame: 10 minutes after intubation
vital signs
oxygen saturation (%)
Time frame: 60 minutes after prone positioning
vital signs
heart rate (BPM)
Time frame: 10 minutes after intubation
vital signs
heart rate (BPM)
Time frame: 60 minutes after prone positioning
arterial blood gas analysis, if patients has arterial catheter
oxygen and cardon dioxide tension
Time frame: 10 minutes after intubation & 60 minutes after prone positioning

Study locations

1 of 1 sites recruiting

Seoul National University Hospital
Seoul, South Korea
- Hee-Soo Kim, M.D.,Ph.D. · Contact · dami0605@snu.ac.kr · 02-2072-3664
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Dec 2023, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 6, 2023
First posted: Feb 14, 2023
StartActual: Oct 17, 2022
Primary completionEst.: Dec 31, 2023
CompletionEst.: Aug 31, 2024
Last update: Feb 14, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05726877
Lead sponsor: Seoul National University Hospital
Responsible party: Sponsor
First posted: Feb 14, 2023
Start date: Oct 17, 2022
Primary completion: Dec 31, 2023 (estimated)
Completion: Aug 31, 2024 (estimated)
Last update: Feb 14, 2023

Study contacts

Hee-Soo Kim, M.D., Ph.D.

Contact

dami0605@snu.ac.kr

02-2072-3664

Hee-Soo Kim, MD.Ph.D.

study chair · Professor

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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