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

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™.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Intubation; Difficult or Failed; Supraglottic Airway Device
• Intervention / Treatment: Procedure: Standard method; Procedure: Hean and Neck Rotation

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Experimental: 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.	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Karam Nam, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Intubation; Supraglottic airway device; Airway
• Other Study ID Numbers: LMA_HNRotation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No