Paratracheal PressureNCT03908411
The Effect of Paratracheal Pressure on the Glottic View
A study testing Paratracheal pressure and Sellick's maneuver in people with Paratracheal Pressure and Sellick's Maneuver, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paratracheal Pressure, Sellick's Maneuver, Airway Management
- What is being tested?
- Paratracheal pressure and Sellick's maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 5 Sep 2019to 28 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient undergoing elective surgery with general anesthesia
Who cannot join
- A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, 07061
SMG - SNU Boramae Medical Center
Seoul, 07061
About this study
Official title: The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.
Read the detailed description
Primary outcome:
-Cormack-Lehane grade
Secondary outcome:
- POGO score before and after application of each intervention
- Difficulties of mask ventilation after application of each intervention
- Inspiratory pressure and tidal volume during manual mask ventilation
- Rates of worsening of the glottic view after intervention
- The difficulty of endotracheal intubation
- Intubation time
- Being tested
- Paratracheal pressure, Sellick's maneuver
- Keywords
- Paratracheal pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paratracheal pressureProcedure or surgery
Paratracheal pressure is applied by 30N force with the ultrasound transducer.
Sellick's maneuverProcedure or surgery
Conventional Sellick's maneuver is applied by 30N force
| Study group | Role | What they receive |
|---|---|---|
| Paratracheal pressure | Active comparator | Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus. Receives: Procedure: Paratracheal pressure |
| Sellick's maneuver | Active comparator | Conventional Sellick's maneuver is applied. Receives: Procedure: Sellick's maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane grade
Cormack-Lehane grade
Measured: During anesthesia induction procedure
Secondary outcomes (5)
POGO
The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%, higher value represent a better view
Measured: During anesthesia induction procedure
Difficulty of mask ventilation
Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
Measured: During anesthesia induction procedure
Inspiration pressure
Pressure to maintain adequated ventilation after application of the intervention
Measured: During anesthesia induction procedure
Tidal volume
Tidal volume which is achieved after application of the intervention
Measured: During anesthesia induction procedure
Intubation difficulty
Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult
Measured: During anesthesia induction procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start5 Sep 2019
- Primary completion25 Feb 2020
- Study completion28 Feb 2020
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 Paratracheal PressureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908411
- Sponsor's protocol ID
- 10-2019-16
- Status last verified
- Oct 2020
- First submitted
- 5 Apr 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Won D, Kim H, Chang JE, Lee JM, Min SW, Ma S, Kim C, Hwang JY, Kim TK. Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy: A Randomized Double-Blind, Noninferiority Trial. Anesth Analg. 2021 Aug 1;133(2):491-499. doi: 10.1213/ANE.0000000000005620.
PubMed 34081034
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03908411
- Acronym / sponsor ID
- 10-2019-16
- Keywords
- Paratracheal pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 Apr 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.
Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.
Detailed description
Primary outcome:
-Cormack-Lehane grade
Secondary outcome:
- POGO score before and after application of each intervention
- Difficulties of mask ventilation after application of each intervention
- Inspiratory pressure and tidal volume during manual mask ventilation
- Rates of worsening of the glottic view after intervention
- The difficulty of endotracheal intubation
- Intubation time
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paratracheal pressure | Active comparator | Procedure: Paratracheal pressureLeft Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus. |
| Sellick's maneuver | Active comparator | Procedure: Sellick's maneuverConventional Sellick's maneuver is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient undergoing elective surgery with general anesthesia
Key exclusion criteria (1 listed)
- A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.
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 |
|---|---|---|
| Paratracheal pressureParatracheal pressure is applied by 30N force with the ultrasound transducer. | Procedure or surgery | Paratracheal pressure |
| Sellick's maneuverConventional Sellick's maneuver is applied by 30N force | Procedure or surgery | Sellick's maneuver |
Primary outcome
Cormack-Lehane grade
Time frame: During anesthesia induction procedure
Cormack-Lehane grade
5 secondary outcomes
POGO
Time frame: During anesthesia induction procedure
Difficulty of mask ventilation
Time frame: During anesthesia induction procedure
Inspiration pressure
Time frame: During anesthesia induction procedure
Tidal volume
Time frame: During anesthesia induction procedure
Intubation difficulty
Time frame: During anesthesia induction procedure
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 3 Nov 2020.
- Derived from this study: PubMed 34081034Won D, Kim H, Chang JE, Lee JM, Min SW, Ma S, Kim C, Hwang JY, Kim TK. Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy: A Randomized Double-Blind, Noninferiority Trial. Anesth Analg. 2021 Aug 1;133(2):491-499. doi: 10.1213/ANE.0000000000005620.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paratracheal pressure and Sellick's maneuver in people with Paratracheal Pressure and Sellick's Maneuver, run by Seoul National University Hospital at 2 sites 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 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cormack-Lehane grade (time frame: During anesthesia induction procedure). 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 NCT03908411, 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 3 Nov 2020.