Infants Aged 0 Days to 13 Months Scheduled for Elective SurgeryNCT05373589
Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant
A study testing conventional ventilation, group C and pressure support, group PS in people with Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Atelectasis occurs in patients of all ages who receive mechanical ventilation under general anesthesia, and although fatal cases are rare, it is known as a cause of postoperative hypoxia or fever. Read more about this study
- Who is it for?
- Ages 0 years to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery
- What is being tested?
- conventional ventilation, group C and pressure support, group PS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2022to Feb 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 0 years to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infant patients aged 0 day to 13 month
- American Society of Anesthesiologists (ASA) classification 1~2 who are scheduled for elective surgery under general anesthesia
Who cannot join
- patients with symptomatic bronchopulmonary dysplasia
- patients with uncorrected congenital heart or pulmonary disease
- Hemodynamically unstable requiring preoperative vasopressor administration
- fever (>37.5°) or URI symptoms on the day of surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Jeong-Rim Lee, 82-2-2224-4135, manya@yuhs.ac
About this study
Atelectasis occurs in patients of all ages who receive mechanical ventilation under general anesthesia, and although fatal cases are rare, it is known as a cause of postoperative hypoxia or fever. In pediatric patients, it has a particularly high incidence of 68-100%, and the incidence is inversely proportional to age. Pediatric patients,compared to adults, have a small capacity for functional residual capacity while a high metabolic demand, making them fundamentally vulnerable to hypoxia. Increased atelectasis during anesthesia causes hypoxia not only during anesthesia but also during recovery after anesthesia. Therefore, it is important to establish and apply a strategy to minimize the occurrence of atelectasis during mechanical ventilation under general anesthesia in pediatric patients. The aim of this study is to investigate whether pressure support ventilation at emergence period could reduce the incidence of postoperative atelectasis in infants undergoing surgery under general anesthesia.
- Being tested
- conventional ventilation, group C, pressure support, group PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ventilation, group COther
In the conventional ventilation group, after stopping the administration of the inhalation gas, the emergence process is performed by the anesthesiologist assigned to the room. Basically, until spontaneous respiration of the patient is restored, an anesthesiologist can assist respiration by intermittent manual assistance if necessary.
pressure support, group PSOther
In the pressure support group, after stopping the administration of the inhalation gas, switch to the pressure support mode at the emergence period. PEEP 5cmH20 is applied, and the safety backup ventilation rate is set to 12 breaths/min. The flow trigger is set to 1L/min, and the degree of support is made to be 7-8ml of the predicted body weight, and is decreased as the patient's spontaneous breathing is restored.
| Study group | Role | What they receive |
|---|---|---|
| group C | Experimental | Not described Receives: Other: conventional ventilation, group C |
| group PS | Experimental | Not described Receives: Other: pressure support, group PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of atelectasis
Immediately after arriving at the recovery room, lung ultrasound is performed to check for atelectasis.
Measured: Within 5 minutes of arriving at the recovery room
Secondary outcomes (3)
Frequency of atelectasis
After 30 minutes of staying in the recovery room, lung ultrasound was performed to check for atelectasis.
Measured: After 30 minutes of stay in the recovery room
scoring of atelectasis
Perform atelectasis scoring on 12 parts of the lung
Measured: at the time of admission and after 30 minutes of stay in the recovery room
Frequency of desatuation
Check the frequency of desaturation (<95%) during the stay in the recovery room.
Measured: at the time of admission and after 30 minutes of stay in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study startMay 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants Aged 0 Days to 13 Months Scheduled for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373589
- Sponsor's protocol ID
- 4-2022-0119
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant
- ClinicalTrials.gov ID
- NCT05373589
- Acronym / sponsor ID
- 4-2022-0119
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 13 May 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.
Atelectasis occurs in patients of all ages who receive mechanical ventilation under general anesthesia, and although fatal cases are rare, it is known as a cause of postoperative hypoxia or fever. In pediatric patients, it has a particularly high incidence of 68-100%, and the incidence is inversely proportional to age. Pediatric patients,compared to adults, have a small capacity for functional residual capacity while a high metabolic demand, making them fundamentally vulnerable to hypoxia. Increased atelectasis during anesthesia causes hypoxia not only during anesthesia but also during recovery after anesthesia. Therefore, it is important to establish and apply a strategy to minimize the occurrence of atelectasis during mechanical ventilation under general anesthesia in pediatric patients. The aim of this study is to investigate whether pressure support ventilation at emergence period could reduce the incidence of postoperative atelectasis in infants undergoing surgery under general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group C | Experimental | Other: conventional ventilation, group C |
| group PS | Experimental | Other: pressure support, group PS |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infant patients aged 0 day to 13 month
- American Society of Anesthesiologists (ASA) classification 1~2 who are scheduled for elective surgery under general anesthesia
Key exclusion criteria (4 listed)
- patients with symptomatic bronchopulmonary dysplasia
- patients with uncorrected congenital heart or pulmonary disease
- Hemodynamically unstable requiring preoperative vasopressor administration
- fever (>37.5°) or URI symptoms on the day of surgery
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 |
|---|---|---|
| conventional ventilation, group CIn the conventional ventilation group, after stopping the administration of the inhalation gas, the emergence process is performed by the anesthesiologist assigned to the room. Basically, until spontaneous respiration of the patient is restored, an anesthesiologist can assist respiration by intermittent manual assistance if necessary. | Other | group C |
| pressure support, group PSIn the pressure support group, after stopping the administration of the inhalation gas, switch to the pressure support mode at the emergence period. PEEP 5cmH20 is applied, and the safety backup ventilation rate is set to 12 breaths/min. The flow trigger is set to 1L/min, and the degree of support is made to be 7-8ml of the predicted body weight, and is decreased as the patient's spontaneous breathing is restored. | Other | group PS |
Primary outcome
Frequency of atelectasis
Time frame: Within 5 minutes of arriving at the recovery room
Immediately after arriving at the recovery room, lung ultrasound is performed to check for atelectasis.
3 secondary outcomes
Frequency of atelectasis
Time frame: After 30 minutes of stay in the recovery room
scoring of atelectasis
Time frame: at the time of admission and after 30 minutes of stay in the recovery room
Frequency of desatuation
Time frame: at the time of admission and after 30 minutes of stay in the recovery room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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 conventional ventilation, group C and pressure support, group PS in people with Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery, run by Yonsei University 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 4 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 13 May 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 Jeong-Rim Lee (82-2-2224-4135, manya@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of atelectasis (time frame: Within 5 minutes of arriving at the recovery room). 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 13 May 2022.