Positive End Expiratory PressureNCT05275283
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device
A study testing PEEP in people with Positive End Expiratory Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD). Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Positive End Expiratory Pressure
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2022to 30 Dec 2023
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
- SAD was used for mechanical ventilation
Who cannot join
- Abdominal distension, risk of pulmonary aspiration
- Bronchopulmonary dysplasia/respiratory distress syndrome
- Pneumothorax
- Airway surgery
- Thoracic surgery or laparotomy
- Surgery under prone position
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hee-Soo Kim
Seoul, 03080
Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr
Ji-Hyun LEE, MD. PhD, 82-2-2072-3661, muslab6@snu.ac.kr
About this study
The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).
- Conditions
- Positive End Expiratory Pressure
- Being tested
- PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
6 cmH2O of PEEP
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Applying tidal volume 7 ml/kg without PEEP |
| PEEP group | Experimental | Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory system compliance
total lung and chest wall compliance, ml/cmH2O
Measured: at the end of surgery, about 2 hours after starting of mechanical ventilation
Secondary outcomes (5)
Respiratory system compliance
total lung and chest wall compliance, ml/cmH2O
Measured: 10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
oropharyngeal leak pressure
cmH2O
Measured: immediate after SAD insertion
Electrical impedance tomography parameter - dynamic compliance
ventilation/airway pressure (cmH2O)
Measured: throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - regional ventilation delay
assessment of ventilation homogeneity (no unit)
Measured: throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - pulmonary opening pressure
pressure requiring opening of alveoli (cmH2O
Measured: throughout anesthesia (about during 1-3 hours)
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 start3 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End Expiratory PressureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275283
- Sponsor's protocol ID
- 2111-073-1272
- Status last verified
- Mar 2022
- First submitted
- 29 Nov 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device
- ClinicalTrials.gov ID
- NCT05275283
- Acronym / sponsor ID
- 2111-073-1272
- Conditions
- Positive End Expiratory Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- 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 aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Applying tidal volume 7 ml/kg without PEEP |
| PEEP group | Experimental | Other: PEEPApplying tidal volume 7 ml/kg with 6 cmH2O of PEEP |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
- SAD was used for mechanical ventilation
Key exclusion criteria (6 listed)
- Abdominal distension, risk of pulmonary aspiration
- Bronchopulmonary dysplasia/respiratory distress syndrome
- Pneumothorax
- Airway surgery
- Thoracic surgery or laparotomy
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 |
|---|---|---|
| PEEP6 cmH2O of PEEP | Other | PEEP group |
Primary outcome
Respiratory system compliance
Time frame: at the end of surgery, about 2 hours after starting of mechanical ventilation
total lung and chest wall compliance, ml/cmH2O
5 secondary outcomes
Respiratory system compliance
Time frame: 10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
oropharyngeal leak pressure
Time frame: immediate after SAD insertion
Electrical impedance tomography parameter - dynamic compliance
Time frame: throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - regional ventilation delay
Time frame: throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - pulmonary opening pressure
Time frame: throughout anesthesia (about during 1-3 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Positive End Expiratory Pressure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
RecruitingPhase 1/2
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Congenital Heart Disease, Cardiopulmonary Bypass
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Positive End Expiratory Pressure, 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 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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, MD, PhD (02-2072-3659 ext. 82, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory system compliance (time frame: at the end of surgery, about 2 hours after starting of mechanical ventilation). 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 11 Mar 2022.