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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04106635
Other study ID # MED-INT-19-361
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date July 17, 2020

Study information

Verified date January 2021
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date July 17, 2020
Est. primary completion date July 17, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Ajou university hospital Suwon Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The success rate of device insertion Successful insertion of laryngeal mask airway in a maximum of three attempts During induction of anesthesia, an average of 60 seconds
Secondary The grade of fiberoptic bronchoscopic view 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. During induction of anesthesia, an average of 5 minutes
Secondary The time for successful insertion of the device The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke. : During induction of anesthesia, an average of 60 seconds
Secondary Peak inspiratory pressure Peak inspiratory pressure is recorded from mechanical ventilator. At 5 minute after insertion of laryngeal mask airway
Secondary The ease of insertion of device 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 During induction of anesthesia, an average of 60 seconds
Secondary The number of attempts at insertion of device The number of attempts for successful insertion of laryngeal mask airway During induction of anesthesia, an average of 60 seconds
Secondary Success rate in first attempt Successful insertion of laryngeal mask airway in a first attempt : During induction of anesthesia, an average of 60 seconds
Secondary Incidence of intraoperative complications Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device. During the surgery, an average of 2 hours after anesthesia induction
Secondary Incidence of postoperative complications Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting. An average of 2 hours after extubation
Secondary The presence of gastric air insufflation after induction of anesthesia 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. During induction of anesthesia, an average of 5 minutes
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