Intubation ComplicationNCT03992950
Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus
A study testing Maneuvers for occluding esophagus in people with Intubation Complication, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Maneuvers for occluding esophagus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2021to 25 Jan 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study
Who cannot join
- Risk of aspiration
- History of esophageal surgery
- Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
- Known or predicted difficult airway.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During the Induction of Anesthesia
Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy
Read the detailed description
The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.
- Conditions
- Intubation Complication
- Being tested
- Maneuvers for occluding esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maneuvers for occluding esophagusOther
Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
| Study group | Role | What they receive |
|---|---|---|
| Cricoid pressure | Experimental | Cricoid pressure is applied in the anesthetized state and during video laryngoscopy Receives: Other: Maneuvers for occluding esophagus |
| Paratracheal pressure | Experimental | Paratracheal pressure is applied in the anesthetized state and during video laryngoscopy Receives: Other: Maneuvers for occluding esophagus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion of the esophagus
Occlusion of the esophagus is checked with the application of cricoid and paratracheal pressures using esophageal stethoscope. If the esophageal stethoscope is not advanced into the esophagus, it is considered 'occlusion'.
Measured: During 1 minute under videolaryngoscopy
Secondary outcomes (4)
Outer diameter of the esophagus
Outer diameter of the esophagus is measured using ultrasound before and after the application of cricoid and paratracheal pressures.
Measured: During 1 minute after injection of anesthetics during induction of anesthesia
Position of the oesophageal entrance relative to the glottis
Position of the oesophageal entrance relative to the glottis is evaluated.
Measured: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
Position of the upper oesophagus relative to the trachea
Position of the upper oesophagus relative to the trachea trachea is evaluated.
Measured: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
The best laryngeal view
The best laryngeal view is evaluated using the percentage of glottis opening (POGO) score, ranging from 0% to 100%.
Measured: Before and after the application of cricoid and paratracheal force during videolaryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Sep 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03992950
- Sponsor's protocol ID
- P2019-195
- Status last verified
- Feb 2022
- First submitted
- 19 Jun 2019
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effectiveness of Cricoid and Paratracheal Pressures in Occluding the Upper Esophagus Through Induction of Anesthesia and Videolaryngoscopy: A Randomized, Crossover Study. Anesth Analg. 2022 Nov 1;135(5):1064-1072. doi: 10.1213/ANE.0000000000006154. Epub 2022 Aug 1.
PubMed 35913721
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During the Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT03992950
- Acronym / sponsor ID
- P2019-195
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 20 Jun 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.
Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy
Detailed description
The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cricoid pressure | Experimental | Other: Maneuvers for occluding esophagusCricoid pressure is applied in the anesthetized state and during video laryngoscopy |
| Paratracheal pressure | Experimental | Other: Maneuvers for occluding esophagusParatracheal pressure is applied in the anesthetized state and during video laryngoscopy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study
Key exclusion criteria (4 listed)
- Risk of aspiration
- History of esophageal surgery
- Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
- Known or predicted difficult airway.
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 |
|---|---|---|
| Maneuvers for occluding esophagusCricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level | Other | Cricoid pressure, Paratracheal pressure |
Primary outcome
Occlusion of the esophagus
Time frame: During 1 minute under videolaryngoscopy
Occlusion of the esophagus is checked with the application of cricoid and paratracheal pressures using esophageal stethoscope. If the esophageal stethoscope is not advanced into the esophagus, it is considered 'occlusion'.
4 secondary outcomes
Outer diameter of the esophagus
Time frame: During 1 minute after injection of anesthetics during induction of anesthesia
Position of the oesophageal entrance relative to the glottis
Time frame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
Position of the upper oesophagus relative to the trachea
Time frame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
The best laryngeal view
Time frame: Before and after the application of cricoid and paratracheal force during videolaryngoscopy
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 10 Feb 2022.
- Derived from this study: PubMed 35913721Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effectiveness of Cricoid and Paratracheal Pressures in Occluding the Upper Esophagus Through Induction of Anesthesia and Videolaryngoscopy: A Randomized, Crossover Study. Anesth Analg. 2022 Nov 1;135(5):1064-1072. doi: 10.1213/ANE.0000000000006154. Epub 2022 Aug 1.
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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 Maneuvers for occluding esophagus in people with 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 10 Feb 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?
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?
Occlusion of the esophagus (time frame: During 1 minute under videolaryngoscopy). 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 NCT03992950, which also lists 1 linked publication.
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 10 Feb 2022.