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NCT Number: NCT04106635

Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway

Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice.

On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation.

Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.

In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.

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Key information

Conditions

General Anesthesia Pulmonary Aspiration

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou university hospital

Suwon, Gyeonggi-do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
  • American Society of Anesthesiologists Classification 1-2

Exclusion criteria

  • Body mass index > 35 kg/m2
  • High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
  • Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),

Treatment and study plan

Paratracheal pressure

Procedure

To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.

Cricoid Pressure

Procedure

To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.

Primary outcomes

  1. The success rate of device insertion

    Time frame: During induction of anesthesia, an average of 60 seconds

    Successful insertion of laryngeal mask airway in a maximum of three attempts

Secondary outcomes

  1. The grade of fiberoptic bronchoscopic view

    Time frame: During induction of anesthesia, an average of 5 minutes

    The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: < 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: > 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.

  2. The time for successful insertion of the device

    Time frame: : During induction of anesthesia, an average of 60 seconds

    The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.

  3. Peak inspiratory pressure

    Time frame: At 5 minute after insertion of laryngeal mask airway

    Peak inspiratory pressure is recorded from mechanical ventilator.

  4. The ease of insertion of device

    Time frame: During induction of anesthesia, an average of 60 seconds

    The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device

  5. The number of attempts at insertion of device

    Time frame: During induction of anesthesia, an average of 60 seconds

    The number of attempts for successful insertion of laryngeal mask airway

  6. Success rate in first attempt

    Time frame: : During induction of anesthesia, an average of 60 seconds

    Successful insertion of laryngeal mask airway in a first attempt

  7. Incidence of intraoperative complications

    Time frame: During the surgery, an average of 2 hours after anesthesia induction

    Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.

  8. Incidence of postoperative complications

    Time frame: An average of 2 hours after extubation

    Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.

  9. The presence of gastric air insufflation after induction of anesthesia

    Time frame: During induction of anesthesia, an average of 5 minutes

    The presence of gastric air insufflation is defined as an increase in antral cross-sectional area and/or presence of air artifacts in the antrum (comet tail, posterior acoustic shadow) confirmed by ultrasound.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
Jan 13, 2021

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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