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

Not Applicable

Completed

• Conditions: Pulmonary Aspiration; General Anesthesia
• Interventions: Procedure: Cricoid pressure; Procedure: Paratracheal pressure

• Registration Number: NCT04106635
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2020-01-02
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP group	Cricoid pressure	During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger.
PP group	Paratracheal pressure	During the induction of anesthesia, left paratracheal pressure is applied by 30N force with thumb after confirmation of the location of the esophagus using ultrasound.

Primary Outcome Measures

Name	Time	Method
The success rate of device insertion	During induction of anesthesia, an average of 60 seconds	Successful insertion of laryngeal mask airway in a maximum of three attempts

Secondary Outcome Measures

Name	Time	Method
Success rate in first attempt	: During induction of anesthesia, an average of 60 seconds	Successful insertion of laryngeal mask airway in a first attempt
Incidence of postoperative complications	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.
The grade of fiberoptic bronchoscopic view	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.
The time for successful insertion of the device	: 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.
The ease of insertion of device	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
The presence of gastric air insufflation after induction of anesthesia	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.
Peak inspiratory pressure	At 5 minute after insertion of laryngeal mask airway	Peak inspiratory pressure is recorded from mechanical ventilator.
The number of attempts at insertion of device	During induction of anesthesia, an average of 60 seconds	The number of attempts for successful insertion of laryngeal mask airway
Incidence of intraoperative complications	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.

Trial Locations

Locations (1)

Ajou university hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of