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Ultrasound vs. Auscultation for Optimal Depth of the Cuffless RAE Tube

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ClinicalTrials.gov Identifier: NCT04246411
Recruitment Status : Withdrawn (It was confirmed that cuffed RAE tubes with small diameter could be used, so there was no reason to use RAE cuffless tubes.)
First Posted : January 29, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
The aim of this study is to compare the ultrasound-guidance versus auscultation to confirm optimal insertion depth of the cuffless oral Ring-Adair-Elwyn (RAE) endotracheal tube in pediatric patients undergoing general anesthesia.

Condition or disease Intervention/treatment Phase
Intubation Complication Child Ultrasonography Behavioral: Ultrasound-guided determination of cuffless RAE tube depth Behavioral: Auscultation-guided determination of cuffless RAE tube depth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Ultrasound
Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field
Behavioral: Ultrasound-guided determination of cuffless RAE tube depth
  1. Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA
  2. Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field.
  3. Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning

Placebo Comparator: Auscultation
Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field
Behavioral: Auscultation-guided determination of cuffless RAE tube depth
  1. Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA
  2. Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field
  3. Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning




Primary Outcome Measures :
  1. The proportion of optimal location of the cuffless Oral RAE tube (%) [ Time Frame: during operation (until endotracheal extubation) up to 18 hour after induction ]
    The distance between the tip of cuffless RAE tube and right pulmonary artery is within the -5mm ~ +5mm value of the distance between the T2 mid-vertebra and carina (optimal depth)


Secondary Outcome Measures :
  1. M-distance (between the carina and the T2 mid-vertebra) [ Time Frame: during operation up to 18 hour after induction ]
    The distance between T2 mid-vertebra and the carina)

  2. Distance between the optimal depth and the relocated depth [ Time Frame: during operation up to 18 hour after induction ]
    Distance between the optimal depth and the relocated depth

  3. Subglottic diameter at the cricoid cartilage level [ Time Frame: during operation ]
    Subglottic diameter at the cricoid cartilage level using neck US

  4. ID and OD of optimal cuffless oral RAE tube [ Time Frame: during operation up to 18 hour after induction ]
    Internal and external diameter of optimal cuffless oral RAE tube

  5. Time from intubation to confirming the tube depth [ Time Frame: during operation up to 18 hour after induction ]
    Time from intubation to confirming the tube depth (seconds)

  6. Distance between the optimal depth and the manufacturer's recommended depth [ Time Frame: during operation up to 18 hour after induction ]
    Distance between the optimal depth and the manufacturer's recommended depth

  7. Airway leakage pressure [ Time Frame: during operation up to 18 hour after induction ]
    Airway leakage pressure measured by manual ventilation with APL(Adjustable pressure-limiting) valve

  8. Incidence of the intraoperative airway-related events [ Time Frame: during operation up to 18 hour after induction ]
    accidental extubation, endobronchial intubation, desaturation (SpO2 < 95%), etc

  9. Incidence of the airway-related symptoms after extubation [ Time Frame: up to 18 hour after induction ]
    hoarseness, stridor, laryngospasm, chest retraction, etc



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children age under 7 years
  • Undergoing general anesthesia
  • Endobronchial intubation with cuffless oral RAE tube

Exclusion Criteria:

  • Pulmonary disease
  • Active upper respiratory tract infection
  • History of upper or lower respiratory tract infection within 2 weeks
  • Emergent operation
  • Unstable vital sign

Information from the National Library of Medicine

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): NCT04246411


Locations
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Korea, Republic of
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim, MD.PhD Professor, Seoul National University Hospital
Publications:
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Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04246411    
Other Study ID Numbers: US-RAE
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No