Paratracheal PressureNCT05377346
Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.
A study testing Placement of the i-gel in people with Paratracheal Pressure, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
This study aims to compare the effect of paratracheal and cricoid pressure on placement of the i-gel in terms of the success rate of i-gel insertion, time to placement, the rate of optimal position of the device, and difficulty of i-gel placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paratracheal Pressure
- What is being tested?
- Placement of the i-gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2022to 20 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery under general anesthesia
Who cannot join
- Presence of an upper airway anatomic variation or pathology
- Increased risk of pulmonary aspiration
- Known or predicted difficult airway
- Surgery requiring lateral or prone position, head and neck surgery
- Requirements for postoperative ventilator care.
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: A Comparison of the Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.
This study aims to compare the effect of paratracheal and cricoid pressure on placement of the i-gel in terms of the success rate of i-gel insertion, time to placement, the rate of optimal position of the device, and difficulty of i-gel placement.
- Conditions
- Paratracheal Pressure
- Being tested
- Placement of the i-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of the i-gelOther
The lubricated i-gel is inserted into the mouth and introduced along the hard palate with a continuous and gentle push until resistance was felt in the hypopharynx.
| Study group | Role | What they receive |
|---|---|---|
| Paratracheal pressure group | Experimental | After the induction of anesthesia, the i-gel is placed under the application of paratracheal pressure. Receives: Other: Placement of the i-gel |
| Cricoid pressure group | Active comparator | After the induction of anesthesia, the i-gel is placed under the application of cricoid pressure. Receives: Other: Placement of the i-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of the i-gel placement
Successful placement of the i-gel is determined by proper chest expansion, the presence of a square waveform on the capnogram, absence of an audible leak, and lack of gastric insufflations.
Measured: Immediately after the placement of the i-gel
Secondary outcomes (5)
Time to placement of the i-gel
Time to placement is defined as the time from picking up the i-gel to observing the end-tidal CO2 waveform.
Measured: Immediately after the placement of the i-gel
The rate of optimal position of the i-gel
The anatomic position of the device is evaluated using a fiberoptic bronchoscope and graded on a scale of 1-4 as follows: 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation
Measured: Immediately after the placement of the i-gel
Difficulty of the i-gel placement
Difficulty of the i-gel placement is assessed as follows; 1, very easy; 2, easy; 3, moderate; 4, difficult; 5. very difficult
Measured: Immediately after the placement of the i-gel
Tidal volume
Tidal volume is assessed with or without each pressure using the ventilator setting (volume-control mode with a tidal volume of 8 mL/kg of ideal body weight, respiratory rate of 12 breaths/min, and zero end-expiratory pressure).
Measured: At 1 minute after the placement of the i-gel
Peak inspiratory pressure
Peak inspiratory pressure is assessed with or without each pressure using the ventilator setting (volume-control mode with a tidal volume of 8 mL/kg of ideal body weight, respiratory rate of 12 breaths/min, and zero end-expiratory pressure)..
Measured: At 1 minute after the placement of the i-gel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 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
- NCT05377346
- Sponsor's protocol ID
- 202205
- Status last verified
- Jul 2023
- First submitted
- 11 May 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Won D, Kim H, Chang JE, Lee JM, Kim TK, Kim H, Min SW, Hwang JY. Comparison of the effects of paratracheal pressure and cricoid pressure on placement of the i-gel(R) supraglottic airway: a randomized clinical trial. Can J Anaesth. 2024 Jul;71(7):996-1003. doi: 10.1007/s12630-024-02741-1. Epub 2024 Mar 20.
PubMed 38507025
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.
- ClinicalTrials.gov ID
- NCT05377346
- Acronym / sponsor ID
- 202205
- Conditions
- Paratracheal Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 17 May 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.
This study aims to compare the effect of paratracheal and cricoid pressure on placement of the i-gel in terms of the success rate of i-gel insertion, time to placement, the rate of optimal position of the device, and difficulty of i-gel placement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paratracheal pressure group | Experimental | Other: Placement of the i-gelAfter the induction of anesthesia, the i-gel is placed under the application of paratracheal pressure. |
| Cricoid pressure group | Active comparator | Other: Placement of the i-gelAfter the induction of anesthesia, the i-gel is placed under the application of cricoid pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective surgery under general anesthesia
Key exclusion criteria (5 listed)
- Presence of an upper airway anatomic variation or pathology
- Increased risk of pulmonary aspiration
- Known or predicted difficult airway
- Surgery requiring lateral or prone position, head and neck surgery
- Requirements for postoperative ventilator care.
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 |
|---|---|---|
| Placement of the i-gelThe lubricated i-gel is inserted into the mouth and introduced along the hard palate with a continuous and gentle push until resistance was felt in the hypopharynx. | Other | Cricoid pressure group, Paratracheal pressure group |
Primary outcome
The success rate of the i-gel placement
Time frame: Immediately after the placement of the i-gel
Successful placement of the i-gel is determined by proper chest expansion, the presence of a square waveform on the capnogram, absence of an audible leak, and lack of gastric insufflations.
5 secondary outcomes
Time to placement of the i-gel
Time frame: Immediately after the placement of the i-gel
The rate of optimal position of the i-gel
Time frame: Immediately after the placement of the i-gel
Difficulty of the i-gel placement
Time frame: Immediately after the placement of the i-gel
Tidal volume
Time frame: At 1 minute after the placement of the i-gel
Peak inspiratory pressure
Time frame: At 1 minute after the placement of the i-gel
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 1 Aug 2023.
- Derived from this study: PubMed 38507025Won D, Kim H, Chang JE, Lee JM, Kim TK, Kim H, Min SW, Hwang JY. Comparison of the effects of paratracheal pressure and cricoid pressure on placement of the i-gel(R) supraglottic airway: a randomized clinical trial. Can J Anaesth. 2024 Jul;71(7):996-1003. doi: 10.1007/s12630-024-02741-1. Epub 2024 Mar 20.
Related trials for Paratracheal Pressure
Not yet recruiting
Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia
Cerebral Oxygenation
Recruiting
MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children
Surgery, Anesthesia Intubation Complication
Not yet recruiting
PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)
Airway Management
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 Placement of the i-gel in people with Paratracheal Pressure, 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 5 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 1 Aug 2023. 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?
The success rate of the i-gel placement (time frame: Immediately after the placement of the i-gel). 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 NCT05377346, 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 1 Aug 2023.