Clinical trial NCT05201339: Effect of Head-neck Rotation on I-gel™ Insertion
Official title: Effect of Head-neck Rotation on the Success Rate At First Attempt of I-gel™ Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraglottic Airway Device
Intubation; Difficult or Failed
Airway Complication of Anesthesia
Keywords: Supraglottic airway device
Intubation
Airway
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 172
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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™.

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™.

Eligibility criteria: 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)

Primary outcomes:
measure: First attempt success rate
timeFrame: Induction of anesthesia during intraoperative period
Secondary outcomes:
measure: Second attempt success rate
timeFrame: Induction of anesthesia during intraoperative period
measure: Insertion time for successful insertion; s
timeFrame: Induction of anesthesia during intraoperative period
measure: Time required for successful insertion; s
timeFrame: Induction of anesthesia during intraoperative period
measure: Third attempt
timeFrame: Induction of anesthesia during intraoperative period
measure: Third attempt success rate
timeFrame: Induction of anesthesia during intraoperative period
measure: Manipulations required rate
timeFrame: Induction of anesthesia during intraoperative period
measure: Change to intubation
timeFrame: Induction of anesthesia during intraoperative period
measure: Blood staining after extubation
timeFrame: Induction of anesthesia during intraoperative period
measure: Sore throat after extubation
timeFrame: Extubation during intraoperative period
measure: Hoarseness after extubation
timeFrame: Extubation during intraoperative period
measure: Sore throat at 24 hours after surgery
timeFrame: 24 hours after surgery (up to 24hours)
measure: Hoarseness at 24 hours after surgery
timeFrame: 24 hours after surgery (up to 24hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Karam Nam, MD
role: STUDY_DIRECTOR
References: