Effect of Head-neck Rotation on I-gel™ Insertion

NCT ID: NCT05201339

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2023-06-02

Brief 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™.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard method

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.

Group Type: ACTIVE_COMPARATOR

Standard method

Intervention Type: PROCEDURE

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.

Head-neck rotation

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.

Group Type: EXPERIMENTAL

Hean and Neck Rotation

Intervention Type: PROCEDURE

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.

Interventions

Standard method

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.

Intervention Type: PROCEDURE

Hean and Neck Rotation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Those with a recent sore throat
• Those with weak dentation
• Patients at risk of aspiration (Ex: Pregnancy, Gastroesophageal reflux disease or hiatus hernia)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karam Nam, MD

Seoul National University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karam Nam, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 38987667 (View on PubMed)

Other Identifiers

LMA_HNRotation

Identifier Type: -

Identifier Source: org_study_id