Pediatric AnesthesiaNCT03540940
PEEP During Induction of Anesthesia in Small Children
A study testing PEEP and ZEEP in people with Pediatric Anesthesia, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Pediatric Anesthesia
- What is being tested?
- PEEP and ZEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 May 2018to 14 Aug 2019
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients undergoing general anesthesia using endotracheal intubation
Who cannot join
- previous history of lung disease
- anticipated difficulty in airway management
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, 03080
Seoul National University Hospital
Seoul, 03080
About this study
Official title: The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials
Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.
- Conditions
- Pediatric Anesthesia
- Being tested
- PEEP, ZEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
7cmH2O positive end expiratory pressure
ZEEPOther
0 cmH2O positive end expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| zero positive end expiratory pressure | Experimental | Not described Receives: Other: ZEEP |
| Positive end expiratory pressure | Experimental | Not described Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Apnea
Measured: from the start of apnea until SpO2 reached 95%, maximum 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start21 May 2018
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540940
- Sponsor's protocol ID
- H 1804-100-938
- Status last verified
- Aug 2019
- First submitted
- 17 May 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim EH, Lee JH, Jang YE, Ji SH, Cho SA, Kim JT, Kim HS. Effect of positive end-expiratory pressure during anaesthesia induction on non-hypoxic apnoea time in infants: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1012-1018. doi: 10.1097/EJA.0000000000001400.
PubMed 33259454
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03540940
- Acronym / sponsor ID
- H 1804-100-938
- Conditions
- Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 30 May 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.
Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zero positive end expiratory pressure | Experimental | Other: ZEEP |
| Positive end expiratory pressure | Experimental | Other: PEEP |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients undergoing general anesthesia using endotracheal intubation
Key exclusion criteria (2 listed)
- previous history of lung disease
- anticipated difficulty in airway management
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 |
|---|---|---|
| PEEP7cmH2O positive end expiratory pressure | Other | Positive end expiratory pressure |
| ZEEP0 cmH2O positive end expiratory pressure | Other | zero positive end expiratory pressure |
Primary outcome
Duration of Apnea
Time frame: from the start of apnea until SpO2 reached 95%, maximum 5 minutes.
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 19 Aug 2019.
- Derived from this study: PubMed 33259454Kim EH, Lee JH, Jang YE, Ji SH, Cho SA, Kim JT, Kim HS. Effect of positive end-expiratory pressure during anaesthesia induction on non-hypoxic apnoea time in infants: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1012-1018. doi: 10.1097/EJA.0000000000001400.
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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, Professor principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP and ZEEP in people with Pediatric Anesthesia, run by Seoul National University Hospital at 2 sites 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 2 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Duration of Apnea (time frame: from the start of apnea until SpO2 reached 95%, maximum 5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540940, which also lists 1 linked publication.
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 19 Aug 2019.