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

N/ACompletedNCT05201339

Seoul National University Hospital172 enrolled

Overview

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™.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

172

Conditions

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

Interventions

Standard methodPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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.