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

Seoul National University

Status: Completed

Conditions: Supraglottic Airway Device; Airway Complication of Anesthesia; Intubation; Difficult or Failed

Treatments: Procedure: Standard method; Procedure: Hean and Neck Rotation

Study type: Interventional

Funder types: Other

Identifiers

NCT05201339

LMA_HNRotation

Details and patient eligibility

About

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™.

Full 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™.

Enrollment: 172 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups

Standard method

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard method

Head-neck rotation

Experimental group

Description:

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.

Treatment:

Procedure: Hean and Neck Rotation