Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway
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|ClinicalTrials.gov Identifier: NCT04106635|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : January 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia Pulmonary Aspiration||Procedure: Paratracheal pressure Procedure: Cricoid pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized double blinded clinical trial|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.|
|Official Title:||Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway|
|Actual Study Start Date :||January 2, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: PP group
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.
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.
Active Comparator: CP group
During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger.
Procedure: 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.
- 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
- 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.
- 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.
- Peak inspiratory pressure [ Time Frame: At 5 minute after insertion of laryngeal mask airway ]Peak inspiratory pressure is recorded from mechanical ventilator.
- 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
- 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
- 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106635
|Contact: Jong Yeop Kim, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Ajou university hospital||Recruiting|
|Suwon, Gyeonggi-do, Korea, Republic of, 16499|
|Contact: Jong Yeop Kim 82312195574 email@example.com|