Supraglottic Airway DeviceNCT05201339
Effect of Head-neck Rotation on I-gel™ Insertion
A study testing Standard method and Hean and Neck Rotation in people with Supraglottic Airway Device and Intubation; Difficult or Failed, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Supraglottic Airway Device, Intubation; Difficult or Failed, Airway Complication of Anesthesia
- What is being tested?
- Standard method and Hean and Neck Rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2022to 2 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status Classification Grade 1-3
- Patients who can provide written consent to participate in clinical trials
- Patients requiring the I-gel™ during surgery
Who cannot join
- Outpatient surgery
- Patients who have the neurologic disease or cognitive impairment
- Patients who take antipsychotic drugs
- Body mass index > 35 kg/m2
- Mouth opening < 2.5 cm
- Limited neck extension or cervical mobilization (Ex: Atlanto-axial subluxation, History of cervical spine surgery or head and neck surgery)
Show all 9Show fewer
- Those with a recent sore throat
- Those with weak dentation
- Patients at risk of aspiration (Ex: Pregnancy, Gastroesophageal reflux disease or hiatus hernia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Head-neck Rotation on the Success Rate At First Attempt of I-gel™ Insertion
According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
Read the detailed description
I-gel™ insertion has been reported that the success rate of insertion on the first attempt is 78.5%. There may be several causes of insertion failure. Tongue folding is a major obstacle preventing appropriate i-gel™ placement. To solve this problem, the previous study has proven the efficacy of the rotational technical for I-gel™ insertion and reported a success rate of 97%.
However, the rotation of i-gel™ in the oral cavity may be limited, and it may take some learning curve to get used to it. According to previous studies, head and neck rotation increases the cross-sectional area of the upper airway, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
- Conditions
- Supraglottic Airway Device, Intubation; Difficult or Failed, Airway Complication of Anesthesia
- Being tested
- Standard method, Hean and Neck Rotation
- Keywords
- Supraglottic airway device, Intubation, Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard methodProcedure or surgery
Insert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx.
Hean and Neck RotationProcedure or surgery
After rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position.
| Study group | Role | What they receive |
|---|---|---|
| Standard method | Active comparator | Insert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx. Receives: Procedure: Standard method |
| Head-neck rotation | Experimental | After rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position. Receives: Procedure: Hean and Neck Rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Measured: Induction of anesthesia during intraoperative period
Secondary outcomes (12)
Second attempt success rate
After the second attempt on insertion of i-gel™, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Measured: Induction of anesthesia during intraoperative period
Insertion time for successful insertion; s
Time from insertion of i-gel™ into the oral cavity until appropriate placement.
Measured: Induction of anesthesia during intraoperative period
Time required for successful insertion; s
Time insertion of i-gel™ into the oral cavity until After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Measured: Induction of anesthesia during intraoperative period
Third attempt
If the attempt of assigned method fails twice, then try third attempt.
Measured: Induction of anesthesia during intraoperative period
Third attempt success rate
If the attempt of assigned method fails, but the third attempt is successful with another method.
Measured: Induction of anesthesia during intraoperative period
Manipulations required rate
An assistant assists when all attempt fail.
Measured: Induction of anesthesia during intraoperative period
Change to intubation
Conversion rate from insertion of i-gel™ to tracheal intubation.
Measured: Induction of anesthesia during intraoperative period
Blood staining after extubation
Blood stating to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Measured: Induction of anesthesia during intraoperative period
Sore throat after extubation
Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Measured: Extubation during intraoperative period
Hoarseness after extubation
Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Measured: Extubation during intraoperative period
Sore throat at 24 hours after surgery
Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Measured: 24 hours after surgery (up to 24hours)
Hoarseness at 24 hours after surgery
Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Measured: 24 hours after surgery (up to 24hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start25 Feb 2022
- Primary completion2 Jun 2023
- Study completion2 Jun 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 Supraglottic Airway DeviceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Nam, MD, Seoul National University Hospital
- Investigators
- Karam Nam, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201339
- Sponsor's protocol ID
- LMA_HNRotation
- Status last verified
- Oct 2024
- First submitted
- 21 Dec 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Nam K, Park SJ, Ju JW, Cho YJ, Jeon Y. Comparison between head rotation and standard techniques for i-gel insertion: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 10;24(1):229. doi: 10.1186/s12871-024-02621-7.
PubMed 38987667
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head-neck Rotation on the Success Rate At First Attempt of I-gel™ Insertion
- ClinicalTrials.gov ID
- NCT05201339
- Acronym / sponsor ID
- LMA_HNRotation
- Conditions
- Supraglottic Airway Device, Intubation; Difficult or Failed, Airway Complication of Anesthesia
- Keywords
- Supraglottic airway device, Intubation, Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 21 Jan 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.
According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
Detailed description
I-gel™ insertion has been reported that the success rate of insertion on the first attempt is 78.5%. There may be several causes of insertion failure. Tongue folding is a major obstacle preventing appropriate i-gel™ placement. To solve this problem, the previous study has proven the efficacy of the rotational technical for I-gel™ insertion and reported a success rate of 97%.
However, the rotation of i-gel™ in the oral cavity may be limited, and it may take some learning curve to get used to it. According to previous studies, head and neck rotation increases the cross-sectional area of the upper airway, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard method | Active comparator | Procedure: Standard methodInsert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx. |
| Head-neck rotation | Experimental | Procedure: Hean and Neck RotationAfter rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical Status Classification Grade 1-3
- Patients who can provide written consent to participate in clinical trials
- Patients requiring the I-gel™ during surgery
Key exclusion criteria (9 listed)
- Outpatient surgery
- Patients who have the neurologic disease or cognitive impairment
- Patients who take antipsychotic drugs
- Body mass index > 35 kg/m2
- Mouth opening < 2.5 cm
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 |
|---|---|---|
| Standard methodInsert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx. | Procedure or surgery | Standard method |
| Hean and Neck RotationAfter rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position. | Procedure or surgery | Head-neck rotation |
Primary outcome
First attempt success rate
Time frame: Induction of anesthesia during intraoperative period
After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
12 secondary outcomes
Second attempt success rate
Time frame: Induction of anesthesia during intraoperative period
Insertion time for successful insertion; s
Time frame: Induction of anesthesia during intraoperative period
Time required for successful insertion; s
Time frame: Induction of anesthesia during intraoperative period
Third attempt
Time frame: Induction of anesthesia during intraoperative period
Third attempt success rate
Time frame: Induction of anesthesia during intraoperative period
Manipulations required rate
Time frame: Induction of anesthesia during intraoperative period
Change to intubation
Time frame: Induction of anesthesia during intraoperative period
Blood staining after extubation
Time frame: Induction of anesthesia during intraoperative period
Sore throat after extubation
Time frame: Extubation during intraoperative period
Hoarseness after extubation
Time frame: Extubation during intraoperative period
Sore throat at 24 hours after surgery
Time frame: 24 hours after surgery (up to 24hours)
Hoarseness at 24 hours after surgery
Time frame: 24 hours after surgery (up to 24hours)
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 Oct 2024.
- Derived from this study: PubMed 38987667Lee S, Nam K, Park SJ, Ju JW, Cho YJ, Jeon Y. Comparison between head rotation and standard techniques for i-gel insertion: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 10;24(1):229. doi: 10.1186/s12871-024-02621-7.
- 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.
Karam Nam, MD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard method and Hean and Neck Rotation in people with Supraglottic Airway Device and Intubation; Difficult or Failed, run by Seoul National University Hospital 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 3 inclusion and 9 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 Oct 2024. 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?
First attempt success rate (time frame: Induction of anesthesia during intraoperative period). 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 NCT05201339, 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 Oct 2024.