Endotracheal IntubationNCT05128968
Head and Neck Positions for Endotracheal Intubation Using a Videolaryngoscope
A study testing endotracheal intubation in people with Endotracheal Intubation, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2021to 9 Dec 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general anesthesia
Who cannot join
- Limited neck extension
- Anatomical anomalies or history of surgery in the upper airway
- Weak teeth
- Risk of pulmonary aspiration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: Impact of Head and Neck Positions on Endotracheal Intubation Using a McGRATH MAC Video Laryngoscope
In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.
- Conditions
- Endotracheal Intubation
- Being tested
- endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubationProcedure or surgery
Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Simple extension | Experimental | After induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope. Receives: Procedure: endotracheal intubation |
| Head elevated position | Experimental | After induction of anesthesia, endotracheal intubation was performed in a head elevated position with a pillow using a McGrath MAC videolaryngoscope. Receives: Procedure: endotracheal intubation |
| Sniffing position | Experimental | After induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope. Receives: Procedure: endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of intubation
Ease of endotracheal intubation is assessed using the intubation difficulty scale.
Intubation difficulty scale includes number of attempts, number of operators, number of alternative techniques, glottic opening and so on.
Measured: Procedure (During endotracheal intubation)
Secondary outcomes (8)
Percentage of glottic opening (POGO) score
POGO score is recorded during endotracheal intubation (0%: no visualization of glottic opening; 100%: entire visualization of the glottic opening).
Measured: Procedure (During endotracheal intubation)
Number of attempts
Number of attempts for endotracheal intubation is recorded.
Measured: Procedure (At the end of endotracheal intubation)
Intubation time
The time taken for endotracheal intubation is recorded.
Measured: Procedure (During endotracheal intubation)
Palatopharyngeal wall injury
Presence of palatopharyngeal wall injury is observed.
Measured: Procedure (During endotracheal intubation)
Lifting force for exposure of the glottis
Requirement for lifting force to expose the glottis is recorded during videolaryngoscopy
Measured: Procedure (During endotracheal intubation)
Laryngeal pressure for exposure of the glottis
Requirement for laryngeal force to expose the glottis is recorded during videolaryngoscopy
Measured: Procedure (During endotracheal intubation)
Lifting force for advancing an endotracheal tube into the larynx
Requirement for lifting force is recorded during the advancement of the endotracheal tube into the larynx.
Measured: Procedure (During endotracheal intubation)
Laryngeal pressure for advancing an endotracheal tube into the larynx.
Requirement for laryngeal pressure is recorded during the advancement of the endotracheal tube into the larynx.
Measured: Procedure (During endotracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Dec 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, PhD., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128968
- Sponsor's protocol ID
- 11-2021
- Status last verified
- Dec 2022
- First submitted
- 11 Nov 2021
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effect of head and neck positions on tracheal intubation using a McGRATH MAC video laryngoscope: A randomised, prospective study. Eur J Anaesthesiol. 2023 Aug 1;40(8):560-567. doi: 10.1097/EJA.0000000000001838. Epub 2023 Apr 13.
PubMed 37052067
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Head and Neck Positions on Endotracheal Intubation Using a McGRATH MAC Video Laryngoscope
- ClinicalTrials.gov ID
- NCT05128968
- Acronym / sponsor ID
- 11-2021
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 22 Nov 2021 (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.
In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple extension | Experimental | Procedure: endotracheal intubationAfter induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope. |
| Head elevated position | Experimental | Procedure: endotracheal intubationAfter induction of anesthesia, endotracheal intubation was performed in a head elevated position with a pillow using a McGrath MAC videolaryngoscope. |
| Sniffing position | Experimental | Procedure: endotracheal intubationAfter induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for general anesthesia
Key exclusion criteria (4 listed)
- Limited neck extension
- Anatomical anomalies or history of surgery in the upper airway
- Weak teeth
- Risk of pulmonary aspiration
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 |
|---|---|---|
| endotracheal intubationEndotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope. | Procedure or surgery | Head elevated position, Simple extension, Sniffing position |
Primary outcome
Ease of intubation
Time frame: Procedure (During endotracheal intubation)
Ease of endotracheal intubation is assessed using the intubation difficulty scale. Intubation difficulty scale includes number of attempts, number of operators, number of alternative techniques, glottic opening and so on.
8 secondary outcomes
Percentage of glottic opening (POGO) score
Time frame: Procedure (During endotracheal intubation)
Number of attempts
Time frame: Procedure (At the end of endotracheal intubation)
Intubation time
Time frame: Procedure (During endotracheal intubation)
Palatopharyngeal wall injury
Time frame: Procedure (During endotracheal intubation)
Lifting force for exposure of the glottis
Time frame: Procedure (During endotracheal intubation)
Laryngeal pressure for exposure of the glottis
Time frame: Procedure (During endotracheal intubation)
Lifting force for advancing an endotracheal tube into the larynx
Time frame: Procedure (During endotracheal intubation)
Laryngeal pressure for advancing an endotracheal tube into the larynx.
Time frame: Procedure (During endotracheal intubation)
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 29 Dec 2022.
- Derived from this study: PubMed 37052067Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effect of head and neck positions on tracheal intubation using a McGRATH MAC video laryngoscope: A randomised, prospective study. Eur J Anaesthesiol. 2023 Aug 1;40(8):560-567. doi: 10.1097/EJA.0000000000001838. Epub 2023 Apr 13.
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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.
Jin-Young Hwang, PhD. principal investigator
SMG-SNU Boramae 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 endotracheal intubation in people with Endotracheal Intubation, run by SMG-SNU Boramae Medical Center 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 4 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 29 Dec 2022. 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?
Ease of intubation (time frame: Procedure (During endotracheal intubation)). 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 NCT05128968, which also lists 1 linked publication.
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 29 Dec 2022.