Anesthesia Intubation ComplicationNCT04110899
Paratracheal Force Required for Occluding the Upper Esophagus
A study testing Application of paratracheal force in people with Anesthesia Intubation Complication, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Application of paratracheal force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2020to 10 Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled for elective surgery under general anesthesia
Who cannot join
- diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus
- aspiration tendency
- history of carotid artery diseases or cerebrovascular diseases
- suspicious of thrombus in carotid artery on ultrasonographic examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients
In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Application of paratracheal force
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of paratracheal forceOther
An esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients.
| Study group | Role | What they receive |
|---|---|---|
| Different paratracheal force | Experimental | Esophageal occlusion is assessed by inserting an esophageal stethoscope under different paratracheal forces. Receives: Other: Application of paratracheal force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median paratracheal force
Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope
Measured: During 1 min after the completion of anesthesia induction
Secondary outcomes (1)
The 95% paratracheal force
Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope
Measured: During 1 min after the completion of anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Mar 2020
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Model description
- Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.
- Masking
- None (open label)
- Enrolment
- 47 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110899
- Sponsor's protocol ID
- 2019-6209
- Status last verified
- Jun 2020
- First submitted
- 26 Sep 2019
- Last updated
- 19 Jun 2020
- 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients
- ClinicalTrials.gov ID
- NCT04110899
- Acronym / sponsor ID
- 2019-6209
- Conditions
- Anesthesia Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 1 Oct 2019 (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.
In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.
Study design
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.
| Arm | Type | Receives |
|---|---|---|
| Different paratracheal force | Experimental | Other: Application of paratracheal forceEsophageal occlusion is assessed by inserting an esophageal stethoscope under different paratracheal forces. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are scheduled for elective surgery under general anesthesia
Key exclusion criteria (4 listed)
- diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus
- aspiration tendency
- history of carotid artery diseases or cerebrovascular diseases
- suspicious of thrombus in carotid artery on ultrasonographic examination
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 |
|---|---|---|
| Application of paratracheal forceAn esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients. | Other | Different paratracheal force |
Primary outcome
Median paratracheal force
Time frame: During 1 min after the completion of anesthesia induction
Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope
1 secondary outcome
The 95% paratracheal force
Time frame: During 1 min after the completion of anesthesia induction
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 Jun 2020.
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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 Application of paratracheal force in people with Anesthesia 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 1 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 19 Jun 2020. 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?
Median paratracheal force (time frame: During 1 min after the completion of anesthesia induction). 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 19 Jun 2020.