Supraglottic Airway Device, Intubation; Difficult or Failed, Airway Complication of Anesthesia
Conditions
Keywords
Supraglottic airway device, Intubation, Airway
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™.
Interventions
PROCEDUREStandard 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.
PROCEDUREHean 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First attempt success rate | Induction of anesthesia during intraoperative period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second attempt success rate | Induction of anesthesia during intraoperative period | 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 required for successful insertion; s | Induction of anesthesia during intraoperative period | 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. |
| Third attempt | Induction of anesthesia during intraoperative period | If the attempt of assigned method fails twice, then try third attempt. |
| Third attempt success rate | Induction of anesthesia during intraoperative period | If the attempt of assigned method fails, but the third attempt is successful with another method. |
| Manipulations required rate | Induction of anesthesia during intraoperative period | An assistant assists when all attempt fail. |
| Insertion time for successful insertion; s | Induction of anesthesia during intraoperative period | Time from insertion of i-gel™ into the oral cavity until appropriate placement. |
| Blood staining after extubation | Induction of anesthesia during intraoperative period | Blood stating to evaluate the postoperative complication and outcome in patients received each intubation method during surgery |
| Sore throat after extubation | Extubation during intraoperative period | Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery |
| Hoarseness after extubation | Extubation during intraoperative period | Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery |
| Sore throat at 24 hours after surgery | 24 hours after surgery (up to 24hours) | Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery |
| Hoarseness at 24 hours after surgery | 24 hours after surgery (up to 24hours) | Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery |
| Change to intubation | Induction of anesthesia during intraoperative period | Conversion rate from insertion of i-gel™ to tracheal intubation. |
Countries
South Korea
Outcome results
None listed