Intubation ComplicationNCT04246411
Ultrasound vs. Auscultation for Optimal Depth of the Cuffless RAE Tube
A study testing Ultrasound-guided determination of cuffless RAE tube depth and Auscultation-guided determination of cuffless RAE tube depth in people with Intubation Complication and Child, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation Complication, Child, Ultrasonography
- What is being tested?
- Ultrasound-guided determination of cuffless RAE tube depth and Auscultation-guided determination of cuffless RAE tube depth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age under 7 years
- Undergoing general anesthesia
- Endobronchial intubation with cuffless oral RAE tube
Who cannot join
- Pulmonary disease
- Active upper respiratory tract infection
- History of upper or lower respiratory tract infection within 2 weeks
- Emergent operation
- Unstable vital sign
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intubation Complication, Child, Ultrasonography
- Being tested
- Ultrasound-guided determination of cuffless RAE tube depth, Auscultation-guided determination of cuffless RAE tube depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided determination of cuffless RAE tube depthBehavioural
- Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA
- Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field.
- Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning
Auscultation-guided determination of cuffless RAE tube depthBehavioural
- Measurement of "Carina-T2 mid-vertebra length" from preoperative Cheat PA
- Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field
- Withdrawal of the cuffless RAE tube using the "Carina-T2 mid-vertebra length" for optimal positioning
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field Receives: Behavioral: Ultrasound-guided determination of cuffless RAE tube depth |
| Auscultation | Placebo comparator | Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field Receives: Behavioral: Auscultation-guided determination of cuffless RAE tube depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of optimal location of the cuffless Oral RAE tube (%)
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)
Measured: during operation (until endotracheal extubation) up to 18 hour after induction
Secondary outcomes (9)
M-distance (between the carina and the T2 mid-vertebra)
The distance between T2 mid-vertebra and the carina)
Measured: during operation up to 18 hour after induction
Distance between the optimal depth and the relocated depth
Distance between the optimal depth and the relocated depth
Measured: during operation up to 18 hour after induction
Subglottic diameter at the cricoid cartilage level
Subglottic diameter at the cricoid cartilage level using neck US
Measured: during operation
ID and OD of optimal cuffless oral RAE tube
Internal and external diameter of optimal cuffless oral RAE tube
Measured: during operation up to 18 hour after induction
Time from intubation to confirming the tube depth
Time from intubation to confirming the tube depth (seconds)
Measured: during operation up to 18 hour after induction
Distance between the optimal depth and the manufacturer's recommended depth
Distance between the optimal depth and the manufacturer's recommended depth
Measured: during operation up to 18 hour after induction
Airway leakage pressure
Airway leakage pressure measured by manual ventilation with APL(Adjustable pressure-limiting) valve
Measured: during operation up to 18 hour after induction
Incidence of the intraoperative airway-related events
accidental extubation, endobronchial intubation, desaturation (SpO2 < 95%), etc
Measured: during operation up to 18 hour after induction
Incidence of the airway-related symptoms after extubation
hoarseness, stridor, laryngospasm, chest retraction, etc
Measured: up to 18 hour after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: It was confirmed that cuffed RAE tubes with small diameter could be used, so there was no reason to use RAE cuffless tubes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD.PhD, Principal investigator, Professor, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246411
- Sponsor's protocol ID
- US-RAE
- Status last verified
- Oct 2020
- First submitted
- 14 Jan 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altun D, Orhan-Sungur M, Ali A, Ozkan-Seyhan T, Sivrikoz N, Camci E. The role of ultrasound in appropriate endotracheal tube size selection in pediatric patients. Paediatr Anaesth. 2017 Oct;27(10):1015-1020. doi: 10.1111/pan.13220. Epub 2017 Aug 28.
PubMed 28846176Ahn JH, Kwon E, Lee SY, Hahm TS, Jeong JS. Ultrasound-guided lung sliding sign to confirm optimal depth of tracheal tube insertion in young children. Br J Anaesth. 2019 Sep;123(3):309-315. doi: 10.1016/j.bja.2019.03.020. Epub 2019 Apr 12.
PubMed 30987765
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04246411
- Acronym / sponsor ID
- US-RAE
- Conditions
- Intubation Complication, Child, Ultrasonography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was confirmed that cuffed RAE tubes with small diameter could be used, so there was no reason to use RAE cuffless tubes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Behavioral: Ultrasound-guided determination of cuffless RAE tube depthUltrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field |
| Auscultation | Placebo comparator | Behavioral: Auscultation-guided determination of cuffless RAE tube depthAuscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children age under 7 years
- Undergoing general anesthesia
- Endobronchial intubation with cuffless oral RAE tube
Key exclusion criteria (5 listed)
- Pulmonary disease
- Active upper respiratory tract infection
- History of upper or lower respiratory tract infection within 2 weeks
- Emergent operation
- Unstable vital sign
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided determination of cuffless RAE tube depth1. 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 | Behavioural | Ultrasound |
| Auscultation-guided determination of cuffless RAE tube depth1. 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 | Behavioural | Auscultation |
Primary outcome
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)
9 secondary outcomes
M-distance (between the carina and the T2 mid-vertebra)
Time frame: 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
Subglottic diameter at the cricoid cartilage level
Time frame: during operation
ID and OD of optimal cuffless oral RAE tube
Time frame: 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
Distance between the optimal depth and the manufacturer's recommended depth
Time frame: during operation up to 18 hour after induction
Airway leakage pressure
Time frame: 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
Incidence of the airway-related symptoms after extubation
Time frame: up to 18 hour after induction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 28846176Altun D, Orhan-Sungur M, Ali A, Ozkan-Seyhan T, Sivrikoz N, Camci E. The role of ultrasound in appropriate endotracheal tube size selection in pediatric patients. Paediatr Anaesth. 2017 Oct;27(10):1015-1020. doi: 10.1111/pan.13220. Epub 2017 Aug 28.
- Background: PubMed 30987765Ahn JH, Kwon E, Lee SY, Hahm TS, Jeong JS. Ultrasound-guided lung sliding sign to confirm optimal depth of tracheal tube insertion in young children. Br J Anaesth. 2019 Sep;123(3):309-315. doi: 10.1016/j.bja.2019.03.020. Epub 2019 Apr 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, MD.PhD principal investigator
Professor, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided determination of cuffless RAE tube depth and Auscultation-guided determination of cuffless RAE tube depth in people with Intubation Complication and Child, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of optimal location of the cuffless Oral RAE tube (%) (time frame: during operation (until endotracheal extubation) up to 18 hour after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.