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Completed

NCT Number: NCT05201339

Effect of Head-neck Rotation on 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™.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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™.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard method

Procedure

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

Procedure

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.

Primary outcomes

  1. First attempt success rate

    Time frame: 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 outcomes

  1. Second attempt success rate

    Time frame: 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.

  2. Insertion time for successful insertion; s

    Time frame: Induction of anesthesia during intraoperative period

    Time from insertion of i-gel™ into the oral cavity until appropriate placement.

  3. Time required for successful insertion; s

    Time frame: 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.

  4. Third attempt

    Time frame: Induction of anesthesia during intraoperative period

    If the attempt of assigned method fails twice, then try third attempt.

  5. Third attempt success rate

    Time frame: Induction of anesthesia during intraoperative period

    If the attempt of assigned method fails, but the third attempt is successful with another method.

  6. Manipulations required rate

    Time frame: Induction of anesthesia during intraoperative period

    An assistant assists when all attempt fail.

  7. Change to intubation

    Time frame: Induction of anesthesia during intraoperative period

    Conversion rate from insertion of i-gel™ to tracheal intubation.

  8. Blood staining after extubation

    Time frame: Induction of anesthesia during intraoperative period

    Blood stating to evaluate the postoperative complication and outcome in patients received each intubation method during surgery

  9. Sore throat after extubation

    Time frame: Extubation during intraoperative period

    Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery

  10. Hoarseness after extubation

    Time frame: Extubation during intraoperative period

    Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery

  11. Sore throat at 24 hours after surgery

    Time frame: 24 hours after surgery (up to 24hours)

    Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery

  12. Hoarseness at 24 hours after surgery

    Time frame: 24 hours after surgery (up to 24hours)

    Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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