An interventional study of Standard method and Hean and Neck Rotation in Supraglottic Airway Device, Intubation; Difficult or Failed and Airway Complication of Anesthesia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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™.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Induction of anesthesia during intraoperative period
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.
Time frame: 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.
Time frame: 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.
Time frame: Induction of anesthesia during intraoperative period
Third attempt
If the attempt of assigned method fails twice, then try third attempt.
Time frame: 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.
Time frame: Induction of anesthesia during intraoperative period
Manipulations required rate
An assistant assists when all attempt fail.
Time frame: Induction of anesthesia during intraoperative period
Change to intubation
Conversion rate from insertion of i-gel™ to tracheal intubation.
Time frame: 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
Time frame: 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
Time frame: Extubation during intraoperative period
Hoarseness after extubation
Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Time frame: 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
Time frame: 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
Time frame: 24 hours after surgery (up to 24hours)
Plan to share: No
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Seoul National University Hospital