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

Study Overview
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Brief Summary
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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
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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™.

Official Title
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Effect of Head-neck Rotation on the Success Rate at First Attempt of I-gel™ Insertion

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

Intervention / Treatment
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* Procedure: Standard method
* Procedure: Hean and Neck Rotation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard method<br>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. | Procedure: Standard method<br>* 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.<br>|
| Experimental: Head-neck rotation<br>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. | Procedure: Hean and Neck Rotation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Induction of anesthesia during intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Induction of anesthesia during intraoperative period | 
| Third attempt | If the attempt of assigned method fails twice, then try third attempt. | 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. | Induction of anesthesia during intraoperative period | 
| Manipulations required rate | An assistant assists when all attempt fail. | Induction of anesthesia during intraoperative period | 
| Change to intubation | Conversion rate from insertion of i-gel™ to tracheal intubation. | 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 | 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 | Extubation during intraoperative period | 
| Hoarseness after extubation | Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery | 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 | 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 | 24 hours after surgery (up to 24hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic airway device, Airway, Intubation