Intubation;DifficultNCT04457453
Comparison of Direct and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position
A study testing Macintosh in sniffing position, Macintosh in Trendelenburg position and Sellick position and AceScope in Trendelenburg position and Sellick position in people with Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory complications. Takenaka's study of mannequins reported that the risk of airway contamination by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position and a Sellick position with neck… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Macintosh in sniffing position, Macintosh in Trendelenburg position and Sellick position and AceScope in Trendelenburg position and Sellick position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2021to 7 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 19 years old
- ASA I or II
- Patients who need nasotracheal intubation for surgery
Who cannot join
- Anatomical deformity in head and neck
- Patients who have risk of pulmonary aspiration
- Patients with cervical deformities or pain
- BMI >35
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou universitiy school of medicine
Suwon, Gyeong-gi Do, 16499
About this study
Official title: Comparison of Direct Laryngoscope and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position to Prevent Pulmonary Aspiration
Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory complications. Takenaka's study of mannequins reported that the risk of airway contamination by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position and a Sellick position with neck extention. However, the clinical performance of tracheal intubation in this position has not been studied. Also, the difference between the effects of direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.
Therefore, this study aims to compare the intubation time among intubation through direct laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation in the conventional sniffing position.
- Conditions
- Intubation;Difficult
- Being tested
- Macintosh in sniffing position, Macintosh in Trendelenburg position and Sellick position, AceScope in Trendelenburg position and Sellick position
- Keywords
- Trendelenburg position, Sellick position, pulmonary aspiration, video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh in sniffing positionOther
Macintosh direct intubation in sniffing position
Macintosh in Trendelenburg position and Sellick positionOther
Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position
AceScope in Trendelenburg position and Sellick positionOther
AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | intubation with direct laryngoscope in sniffing position Receives: Other: Macintosh in sniffing position |
| direct laryngoscope in Trendelenburg and Sellick position | Experimental | intubation with direct laryngoscope in Trendelenburg and Sellick position Receives: Other: Macintosh in Trendelenburg position and Sellick position |
| video laryngoscope in Trendelenburg and Sellick position | Experimental | intubation with video laryngoscope in Trendelenburg and Sellick position Receives: Other: AceScope in Trendelenburg position and Sellick position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
from endotracheal tube pass the teeth to end-tidal CO2 appear
Measured: within 5 minutes
Secondary outcomes (1)
Intubation difficulty score
Intubation difficulty scale (IDS) score
Measured: within 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start9 Mar 2021
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
- Investigators
- yun jeong chae, Ph.D, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457453
- Sponsor's protocol ID
- AJIRB-MED-OBS-19-507
- Status last verified
- Aug 2023
- First submitted
- 30 Jun 2020
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct Laryngoscope and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position to Prevent Pulmonary Aspiration
- ClinicalTrials.gov ID
- NCT04457453
- Acronym / sponsor ID
- AJIRB-MED-OBS-19-507
- Conditions
- Intubation;Difficult
- Keywords
- Trendelenburg position, Sellick position, pulmonary aspiration, video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 7 Jul 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.
Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory complications. Takenaka's study of mannequins reported that the risk of airway contamination by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position and a Sellick position with neck extention. However, the clinical performance of tracheal intubation in this position has not been studied. Also, the difference between the effects of direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.
Therefore, this study aims to compare the intubation time among intubation through direct laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation in the conventional sniffing position.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Macintosh in sniffing positionintubation with direct laryngoscope in sniffing position |
| direct laryngoscope in Trendelenburg and Sellick position | Experimental | Other: Macintosh in Trendelenburg position and Sellick positionintubation with direct laryngoscope in Trendelenburg and Sellick position |
| video laryngoscope in Trendelenburg and Sellick position | Experimental | Other: AceScope in Trendelenburg position and Sellick positionintubation with video laryngoscope in Trendelenburg and Sellick position |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 19 years old
- ASA I or II
- Patients who need nasotracheal intubation for surgery
Key exclusion criteria (4 listed)
- Anatomical deformity in head and neck
- Patients who have risk of pulmonary aspiration
- Patients with cervical deformities or pain
- BMI >35
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 |
|---|---|---|
| Macintosh in sniffing positionMacintosh direct intubation in sniffing position | Other | control group |
| Macintosh in Trendelenburg position and Sellick positionMacintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position | Other | direct laryngoscope in Trendelenburg and Sellick position |
| AceScope in Trendelenburg position and Sellick positionAceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position | Other | video laryngoscope in Trendelenburg and Sellick position |
Primary outcome
Intubation time
Time frame: within 5 minutes
from endotracheal tube pass the teeth to end-tidal CO2 appear
1 secondary outcome
Intubation difficulty score
Time frame: within 5 minutes
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 25 Aug 2023.
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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.
yun jeong chae, Ph.D principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh in sniffing position, Macintosh in Trendelenburg position and Sellick position and AceScope in Trendelenburg position and Sellick position in people with Intubation;Difficult, run by Ajou University School of Medicine 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 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 25 Aug 2023. 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?
Intubation time (time frame: within 5 minutes). 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 25 Aug 2023.