Intubation ComplicationNCT06210867
Factors Associated With Occluding the Upper Esophagus by Paratracheal Force
An observational study of Intubation Complication, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intubation Complication
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2024to 5 Nov 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were scheduled for general anesthesia without a risk of difficult intubation or a history of head and neck surgery.
Who may be able to join
- ≥ 19 years old
- schedule for general anesthesia
Who cannot join
- Abnormality or anomaly, history of surgery in the neck, esophagus, face, upper airway part.
- Who has weak teeth
- Who has pulmonary aspiration risk
- Who has history of carotid artery or cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure.
Read the detailed description
Measure the sternomental distance, thyromental distance, neck length, neck circumference, Mallampati score, BMI, Neck motion, inter-incisor gap, thyrosternal distance. And analysis these factors are associated with upper esophageal occlusion or not.
- Conditions
- Intubation Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful esophageal occlusion during paratracheal pressure application
Successful esophageal occlusion was defined as the inability to pass an esophageal stethoscope through the esophagus during paratracheal pressure application.
Measured: 10 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start5 Apr 2024
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, MD,PhD, Study chair, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210867
- Sponsor's protocol ID
- 10-2022-111
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
PubMed 8424572Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PubMed 17122571Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.
PubMed 19304443Van de Putte P, Vernieuwe L, Jerjir A, Verschueren L, Tacken M, Perlas A. When fasted is not empty: a retrospective cohort study of gastric content in fasted surgical patientsdagger. Br J Anaesth. 2017 Mar 1;118(3):363-371. doi: 10.1093/bja/aew435.
PubMed 28203725Gautier N, Danklou J, Brichant JF, Lopez AM, Vandepitte C, Kuroda MM, Hadzic A, Gautier PE. The effect of force applied to the left paratracheal oesophagus on air entry into the gastric antrum during positive-pressure ventilation using a facemask. Anaesthesia. 2019 Jan;74(1):22-28. doi: 10.1111/anae.14442. Epub 2018 Oct 4.
PubMed 30288741
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Occluding the Upper Esophagus by Paratracheal Force
- ClinicalTrials.gov ID
- NCT06210867
- Acronym / sponsor ID
- 10-2022-111
- Conditions
- Intubation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 18 Jan 2024 (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.
We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure.
Detailed description
Measure the sternomental distance, thyromental distance, neck length, neck circumference, Mallampati score, BMI, Neck motion, inter-incisor gap, thyrosternal distance. And analysis these factors are associated with upper esophageal occlusion or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were scheduled for general anesthesia without a risk of difficult intubation or a history of head and neck surgery.
Key inclusion criteria (2 listed)
- ≥ 19 years old
- schedule for general anesthesia
Key exclusion criteria (4 listed)
- Abnormality or anomaly, history of surgery in the neck, esophagus, face, upper airway part.
- Who has weak teeth
- Who has pulmonary aspiration risk
- Who has history of carotid artery or cerebrovascular disease
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
Successful esophageal occlusion during paratracheal pressure application
Time frame: 10 sec
Successful esophageal occlusion was defined as the inability to pass an esophageal stethoscope through the esophagus during paratracheal pressure application.
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 27 Oct 2026.
- Background: PubMed 8424572Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
- Background: PubMed 17122571Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
- Background: PubMed 19304443Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.
- Background: PubMed 28203725Van de Putte P, Vernieuwe L, Jerjir A, Verschueren L, Tacken M, Perlas A. When fasted is not empty: a retrospective cohort study of gastric content in fasted surgical patientsdagger. Br J Anaesth. 2017 Mar 1;118(3):363-371. doi: 10.1093/bja/aew435.
- Background: PubMed 30288741Gautier N, Danklou J, Brichant JF, Lopez AM, Vandepitte C, Kuroda MM, Hadzic A, Gautier PE. The effect of force applied to the left paratracheal oesophagus on air entry into the gastric antrum during positive-pressure ventilation using a facemask. Anaesthesia. 2019 Jan;74(1):22-28. doi: 10.1111/anae.14442. Epub 2018 Oct 4.
- Individual participant dataSharing planned: No
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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.
Jin-Young Hwang, MD,PhD study chair
SMG-SNU Boramae Medical Center
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 Intubation Complication, run by SMG-SNU Boramae Medical Center 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: finished, as of the sponsor's last update on 27 Oct 2026. 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?
Successful esophageal occlusion during paratracheal pressure application (time frame: 10 sec). 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 NCT06210867, which also lists 5 linked publications.
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 27 Oct 2026.