Intubation; DifficultTHHEIEIANCT02418741
Head Position for Endotracheal Intubation
A study testing Neck flexion in people with Intubation; Difficult, run by National Medical Center, Seoul at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Neck flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Apr 2014
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective operation time ≤2hrs
- American Society of Anesthesiologist, Physical Status 1 or 2
- age ; 18 - 90 years
Who cannot join
- patient has upper respiratory infection symptoms
- limited mouth opening
- teeth problems
- expecting difficult airway
- congenital heart disease
- patient has a possibility of aspiration pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients
The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.
Read the detailed description
The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.
- Conditions
- Intubation; Difficult
- Being tested
- Neck flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck flexionOther
Patient's neck was flexed using a 4 cm or 8 cm height of pillow
| Study group | Role | What they receive |
|---|---|---|
| Degree of neck flextion | Experimental | Two degrees of neck flexion were achieved using a 4 cm or 8 cm height of pillow Receives: Other: Neck flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal view as index of ease of insertion
Cormack Lehane grade during endotracheal intubation
Measured: one year
Secondary outcomes (1)
Discomfort of anesthesiologist during endotracheal intubation
Anesthesiologist can feel difficulties in mouth opening and in insertion of laryngoscopic blade into oral cavity according to the degrees of neck flexion
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Center, Seoul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Ja Yun, MD, PhD, National Medical Center, Seoul
- Investigators
- Mija Yun, staff, Study director, National medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418741
- Sponsor's protocol ID
- H-1312/037-002
- Acronym
- THHEIEIA
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients
- ClinicalTrials.gov ID
- NCT02418741
- Acronym / sponsor ID
- THHEIEIA / H-1312/037-002
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Medical Center, SeoulUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Apr 2015 (estimated)
- 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 purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.
Detailed description
The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degree of neck flextion | Experimental | Other: Neck flexionTwo degrees of neck flexion were achieved using a 4 cm or 8 cm height of pillow |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective operation time ≤2hrs
- American Society of Anesthesiologist, Physical Status 1 or 2
- age ; 18 - 90 years
Key exclusion criteria (6 listed)
- patient has upper respiratory infection symptoms
- limited mouth opening
- teeth problems
- expecting difficult airway
- congenital heart disease
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 |
|---|---|---|
| Neck flexionPatient's neck was flexed using a 4 cm or 8 cm height of pillow | Other | Degree of neck flextion |
Primary outcome
Laryngeal view as index of ease of insertion
Time frame: one year
Cormack Lehane grade during endotracheal intubation
1 secondary outcome
Discomfort of anesthesiologist during endotracheal intubation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
Mija Yun, staff study director
National medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck flexion in people with Intubation; Difficult, run by National Medical Center, Seoul 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 6 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 21 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Laryngeal view as index of ease of insertion (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.