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

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201339
• Other study ID #: LMA_HNRotation
• Status: Completed
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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