Endotracheal IntubationNCT02158247

Determining the Depth of Endotracheal Tube Insertion

An observational study of Endotracheal Intubation and Individualized Depth of Endotracheal Intubation, run by The Catholic University of Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. Airway length from the medial incisor to carina is divided into four segments ; the length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to vocal cords and vocal cords to carina. 2. Read more about this study

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Endotracheal Intubation, Individualized Depth of Endotracheal Intubation
How many people: 176 participants
Where: 1 siteSouth Korea
Study dates: Jan 2012to Jul 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who are taking operation in the university hospital

Who may be able to join

Patients who are scheduled to take general anesthesia with endotracheal intubation

Who cannot join

Patients undergoing general anesthesia with face mask ventilation or laryngeal mask airway

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Anesthesia and Pain Medicine, Daejeon St Mary's hospital
Daejeon, 301-723

Other trials in South Korea

About this study

Airway length from the medial incisor to carina is divided into four segments ; the length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to vocal cords and vocal cords to carina.
Determining the mean length of each segments with the direct laryngoscope, videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.
Making a new formula to determine the proper individualized depth of intubation on the basis of the length of segments
Virtual experiment : comparing the new formula with conventional method of determining the depth of endotracheal intubation

Conditions: Endotracheal Intubation, Individualized Depth of Endotracheal Intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02158247
Study group	Role	What they receive
Conventional group, Touch and Read group		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Airway Length Between Male and Female
Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.
Measured: Endotracheal intubation time
Airway Length vs Height in Male
Measured: Endotracheal intubation time
Airway Length vs Height in Female
Measured: Endotracheal intubation time

Secondary outcomes (4)

Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male
Normal group is defined as the patients whose airway length from medial incisor to carina is below 25cm.
Conventional method : depth of intubation is 23cm at the medial incisor for male.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male.
Measured: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male
Normal group is defined as the patients whose airway length from medial incisor to carina is over 25cm.
Conventional method : depth of intubation is 23cm at the medial incisor for male.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male.
Measured: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female
Risk group is defined as the patients whose airway length from medial incisor to carina is below 23cm.
Conventional method : depth of intubation is 21cm at the medial incisor for female.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female.
Measured: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female
Normal group is defined as the patients whose airway length from medial incisor to carina is over 23cm.
Conventional method : depth of intubation is 21cm at the medial incisor for female.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female.
Measured: Endotracheal intubation time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jul 2012

First posted6 Jun 2014 (estimated)
Study startJan 2012
Primary completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
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: Observational
Time perspective: Prospective
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02158247
Sponsor's protocol ID: DJSMAN-01
Status last verified: Jun 2014
First submitted: 5 Jun 2014
Last updated: 22 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
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Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
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Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation

All Endotracheal Intubation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Depth of Endotracheal Tube Insertion
ClinicalTrials.gov ID: NCT02158247
Acronym / sponsor ID: DJSMAN-01
Conditions: Endotracheal Intubation, Individualized Depth of Endotracheal Intubation
Study type: Observational
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: The Catholic University of KoreaUniversity, hospital or other
Study start: Jan 2012
Primary completion: Jul 2012 (actual)
First posted: 6 Jun 2014 (estimated)
Results: Posted 22 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Airway length from the medial incisor to carina is divided into four segments ; the length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to vocal cords and vocal cords to carina.
Determining the mean length of each segments with the direct laryngoscope, videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.
Making a new formula to determine the proper individualized depth of intubation on the basis of the length of segments
Virtual experiment : comparing the new formula with conventional method of determining the depth of endotracheal intubation

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Conventional group, Touch and Read group	–	–

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who are taking operation in the university hospital

Key inclusion criteria (1 listed)

Patients who are scheduled to take general anesthesia with endotracheal intubation

Key exclusion criteria (1 listed)

Patients undergoing general anesthesia with face mask ventilation or laryngeal mask airway

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Comparison of Airway Length Between Male and Female
Time frame: Endotracheal intubation time
Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.
Airway Length vs Height in Male
Time frame: Endotracheal intubation time
Airway Length vs Height in Female
Time frame: Endotracheal intubation time

4 secondary outcomes

Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male
Time frame: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male
Time frame: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female
Time frame: Endotracheal intubation time
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female
Time frame: Endotracheal intubation time

Results and safety

Results posted to the registry on 22 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tough and Read Group	181	176

Primary outcome: Comparison of Airway Length Between Male and Female

Time frame: Endotracheal intubation time. Mean (Standard Deviation). Unit: Centimeters

Measure	Airway Length for Male n = 69	Airway Length of Female n = 107
Medial incisor to mouth angle	0.9 (0.5)	1.1 (0.5)
Mouth angle to epiglottis tip	9.1 (1.0)	8.3 (1.0)
Epiglottis tip to vocal cords	4.4 (0.9)	3.6 (0.9)
Vocal cords to carina	11.9 (1.3)	11.2 (1.2)
Medial incisor to carina	26.4 (1.9)	24.2 (1.5)

Primary outcome: Airway Length vs Height in Male

Time frame: Endotracheal intubation time. Mean (Standard Deviation). Unit: Centimeters

Measure	Airway Length vs Height in Male n = 69
Mouth angle to carina	25.5 (1.8)
Mouth angle to epiglottis tip	9.1 (1.0)
Epiglottis tip to vocal cords	4.4 (0.9)
Vocal cords to carina	11.9 (1.3)
Male height	168 (7.4)

Primary outcome: Airway Length vs Height in Female

Time frame: Endotracheal intubation time. Mean (Standard Deviation). Unit: Centimeters

Measure	Female Airway Length vs Height n = 107
Mouth angle to carina	23.2 (1.5)
Mouth angle to epiglottis tip	8.3 (1.0)
Epglottis tip to vocal cords	3.6 (0.9)
Vocal cords to carina	11.2 (1.2)
Female height	156.4 (5.2)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Touch and Read Group(Male)	0 of 71 (0%)	0 of 71 (0%)	Not reported
Touch and Read Group(Female)	0 of 110 (0%)	0 of 110 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Endotracheal Intubation

Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Endotracheal Intubation and Individualized Depth of Endotracheal Intubation, run by The Catholic University of Korea 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 2014. 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. 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?

Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparison of Airway Length Between Male and Female (time frame: Endotracheal intubation time). The study lists 3 primary outcomes in all. 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 NCT02158247.

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 22 Jul 2014.