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

October 12, 2020 updated by: Hee-Soo Kim, Seoul National University Hospital

Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Soul-t'ukpyolsi
      • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
        • Hee-Soo Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
during operation (until endotracheal extubation) up to 18 hour after induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
during operation up to 18 hour after induction
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
during operation up to 18 hour after induction
Subglottic diameter at the cricoid cartilage level
Time Frame: during operation
Subglottic diameter at the cricoid cartilage level using neck US
during operation
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
during operation up to 18 hour after induction
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)
during operation up to 18 hour after induction
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
during operation up to 18 hour after induction
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
during operation up to 18 hour after induction
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
during operation up to 18 hour after induction
Incidence of the airway-related symptoms after extubation
Time Frame: up to 18 hour after induction
hoarseness, stridor, laryngospasm, chest retraction, etc
up to 18 hour after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hee-Soo Kim, MD.PhD, Professor, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US-RAE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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