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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106635
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE September 27, 2019
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE January 2, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04106635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • 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
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway
Official Title  ICMJE Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Other
Condition  ICMJE
  • General Anesthesia
  • Pulmonary Aspiration
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Paratracheal pressure
  • Active Comparator: CP group
    During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger.
    Intervention: Procedure: Cricoid pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2019)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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),
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jong Yeop Kim, MD, PhD 031-219-5579 kjyeop@ajou.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04106635
Other Study ID Numbers  ICMJE MED-INT-19-361
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jong Yeop Kim, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ajou University School of Medicine
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP