ApneaPEEPNCT04722276
Fraction of Oxygen on Induction of Anesthesia in Infants
A study testing positive end expiratory pressure and fraction of inspired oxygen 80% in people with Apnea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Apnea
- What is being tested?
- positive end expiratory pressure and fraction of inspired oxygen 80%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 1 Jul 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.
Who cannot join
- Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia and Non-hypoxic Apnea Time in Infants: a Randomized Controlled Trials
Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.
- Conditions
- Apnea
- Being tested
- positive end expiratory pressure, fraction of inspired oxygen 80%
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive end expiratory pressureOther
7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia
fraction of inspired oxygen 80%Other
fraction of inspired oxygen 80% applied during induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| fraction of inspired oxygen 80% | Active comparator | Not described Receives: Other: fraction of inspired oxygen 80% |
| Fraction of inspired oxygen 80% with positive end expiratory pressure | Experimental | Not described Receives: Other: positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea time
The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%
Measured: during face mask ventilation, maximum 3 minutes.
Secondary outcomes (2)
atelectasis score (0~72)
atelectasis score assessed by lung ultrasound (0-72)
Measured: during anesthesia induction, maximum 5 minutes.
Number of participants with gastric air insufflation
presence of air in the gastric antrum
Measured: during anesthesia induction, 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 posted25 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722276
- Sponsor's protocol ID
- 2012-152-1184
- Acronym
- PEEP
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2021
- Last updated
- 7 Nov 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 7 Nov 2023. 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 and Non-hypoxic Apnea Time in Infants: a Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04722276
- Acronym / sponsor ID
- PEEP / 2012-152-1184
- Conditions
- Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 25 Jan 2021 (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.
Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fraction of inspired oxygen 80% | Active comparator | Other: fraction of inspired oxygen 80% |
| Fraction of inspired oxygen 80% with positive end expiratory pressure | Experimental | Other: positive end expiratory pressure |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.
Key exclusion criteria (1 listed)
- Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.
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 |
|---|---|---|
| positive end expiratory pressure7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia | Other | Fraction of inspired oxygen 80% with positive end expiratory pressure |
| fraction of inspired oxygen 80%fraction of inspired oxygen 80% applied during induction of anesthesia | Other | fraction of inspired oxygen 80% |
Primary outcome
apnea time
Time frame: during face mask ventilation, maximum 3 minutes.
The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%
2 secondary outcomes
atelectasis score (0~72)
Time frame: during anesthesia induction, maximum 5 minutes.
Number of participants with gastric air insufflation
Time frame: during anesthesia induction, 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 7 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive end expiratory pressure and fraction of inspired oxygen 80% in people with Apnea, 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 1 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 7 Nov 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?
apnea time (time frame: during face mask ventilation, maximum 3 minutes.). 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 7 Nov 2023.