Bone Marrow ExaminationNCT05286021
Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
An observational study of Bone Marrow Examination and Urologic Surgical Procedures, run by Yonsei University at 1 site in South Korea.
Trial summary
The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Bone Marrow Examination, Urologic Surgical Procedures, Orthopedic Surgery
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2022to 27 Jan 2024
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will be done in pediatric patients between the ages 2 and 12 years, weight 10 and 30 kg, that are eligible to use the Ambu Auragain LMA for surgical procedures within 2 hours. The patients will undergo surgery in either the supine or prone position.
Who may be able to join
- Pediatric patients undergoing surgery within 2 hours under general anesthesia in either the supine or prone position using the Ambu Auragain LMA.
- Patients aged 2-12 years, weight 10-30 kg, ASA class 1~3
Who cannot join
- Active URI, symptomatic lung disease (uncontrolled asthma, pneumonia etc), patients with history of difficult airway, anticipated difficult mask ventilation, risk of aspiration such as gastroesophageal reflux
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Children undergoing surgery in the supine position using the Ambu Auragain | |
| Prone group | Children undergoing surgery in the prone position using the Ambu Auragain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure immediately after LMA insertion
Oropharyngeal leak pressure is commonly used as a parameter to assess the clinical performance of supraglottic airway devices (SADs). It is defined as the anesthesia circuit pressure at which a gas leak occurs around the SAD.
Measured: During procedure (Immediately after AmbuAuragain LMA insertion)
Secondary outcomes (1)
Oropharyngeal leak pressure 10 minutes after positioning for surgery
Oropharyngeal leak pressure is commonly used as a parameter to assess the clinical performance of supraglottic airway devices (SADs). It is defined as the anesthesia circuit pressure at which a gas leak occurs around the SAD.
Measured: 10 minutes after positioning (either supine or prone position) for surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start5 Jan 2022
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow ExaminationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286021
- Sponsor's protocol ID
- 1-2021-0079
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05286021
- Acronym / sponsor ID
- 1-2021-0079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 18 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 Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | – | –Children undergoing surgery in the supine position using the Ambu Auragain |
| Prone group | – | –Children undergoing surgery in the prone position using the Ambu Auragain |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will be done in pediatric patients between the ages 2 and 12 years, weight 10 and 30 kg, that are eligible to use the Ambu Auragain LMA for surgical procedures within 2 hours. The patients will undergo surgery in either the supine or prone position.
Key inclusion criteria (2 listed)
- Pediatric patients undergoing surgery within 2 hours under general anesthesia in either the supine or prone position using the Ambu Auragain LMA.
- Patients aged 2-12 years, weight 10-30 kg, ASA class 1~3
Key exclusion criteria (1 listed)
- Active URI, symptomatic lung disease (uncontrolled asthma, pneumonia etc), patients with history of difficult airway, anticipated difficult mask ventilation, risk of aspiration such as gastroesophageal reflux
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oropharyngeal leak pressure immediately after LMA insertion
Time frame: During procedure (Immediately after AmbuAuragain LMA insertion)
Oropharyngeal leak pressure is commonly used as a parameter to assess the clinical performance of supraglottic airway devices (SADs). It is defined as the anesthesia circuit pressure at which a gas leak occurs around the SAD.
1 secondary outcome
Oropharyngeal leak pressure 10 minutes after positioning for surgery
Time frame: 10 minutes after positioning (either supine or prone position) for surgery.
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 6 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Bone Marrow Examination
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Not yet recruitingObservational study
Special Stains in Assessment of Bone Marrow Fibrosis
Bone Marrow Fibrosis
RecruitingObservational study
Bone Marrow Imaging and Clinical Outcomes Across Hematologic, Oncologic, and Other Relevant Conditions
Hematologic, Oncologic
Recruiting
Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingObservational study
Muscle Dysfunction in Patients With Haematological Diseases
Hematologic Diseases, Acute Myeloid Leukemia
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?
An observational study of Bone Marrow Examination and Urologic Surgical Procedures, 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 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 6 Jun 2024. 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?
Oropharyngeal leak pressure immediately after LMA insertion (time frame: During procedure (Immediately after AmbuAuragain LMA insertion)). 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 6 Jun 2024.