ManikinNCT04782479
Hand Position for Stylet Removal During Tracheal Intubation
An observational study of Manikin, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators compared the tube movement between two situations; the one was that the practitioner's hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikin's cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Manikin
- What is being tested?
- hand position
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2020to 16 Feb 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Residents in the department of Anesthesia and Pain Medicine
Who may be able to join
- residents in the department of Anesthesia and Pain Medicine
Who cannot join
- refusal for participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: The Effect of Practitioner's Hand Position on Tracheal Tube Movement While Removal of Stylet During Tracheal Intubation
Investigators compared the tube movement between two situations; the one was that the practitioner's hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikin's cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation with a stylet for a manikin.
Read the detailed description
Residents who accepted spontaneous participation were randomly combined into teams of two each. For two residents in a team, each sequentially took on the role of a practitioner and once as an assistant for tracheal intubations by changing the position of the hand holding the tube; one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the manikin. For the assistant role, residents performed stylet removal with two hands. Investigators filmed a video of the tube movement while the assistant pulling up the stylet at 1/8x speed. While analyzing the captured videos, it was measured how much the tube held by the intubation practitioner went in front or how far back during the process of pulling the stylet.
- Conditions
- Manikin
- Being tested
- hand position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand positionProcedure or surgery
For tracheal intubation with a stylet for a manikin, one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the patient, while the assistant pulling back the stylet.
| Study group | Role | What they receive |
|---|---|---|
| in the air | the position of the practitioner's hand holding the tube was placed in the air while the assistant pulling back the stylet. Receives: Procedure: hand position | |
| on the cheek of a manikin | the position of the practitioner's hand holding the tube was placed on the cheek of a manikin while the assistant pulling back the stylet. Receives: Procedure: hand position |
What is being measured
The primary outcome is the main question the study is designed to answer.
tube movement distance
tube movement distance in the process of pulling out the stylet by the assistant
Measured: procedure (at the time when the assistant pulling back the stylet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start11 May 2020
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ManikinStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782479
- Sponsor's protocol ID
- 30-2018-18
- Status last verified
- Sep 2023
- First submitted
- 2 Mar 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Practitioner's Hand Position on Tracheal Tube Movement While Removal of Stylet During Tracheal Intubation
- ClinicalTrials.gov ID
- NCT04782479
- Acronym / sponsor ID
- 30-2018-18
- Conditions
- Manikin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 11 May 2020 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 4 Mar 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.
Investigators compared the tube movement between two situations; the one was that the practitioner's hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikin's cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation with a stylet for a manikin.
Detailed description
Residents who accepted spontaneous participation were randomly combined into teams of two each. For two residents in a team, each sequentially took on the role of a practitioner and once as an assistant for tracheal intubations by changing the position of the hand holding the tube; one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the manikin. For the assistant role, residents performed stylet removal with two hands. Investigators filmed a video of the tube movement while the assistant pulling up the stylet at 1/8x speed. While analyzing the captured videos, it was measured how much the tube held by the intubation practitioner went in front or how far back during the process of pulling the stylet.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in the air | – | Procedure: hand positionthe position of the practitioner's hand holding the tube was placed in the air while the assistant pulling back the stylet. |
| on the cheek of a manikin | – | Procedure: hand positionthe position of the practitioner's hand holding the tube was placed on the cheek of a manikin while the assistant pulling back the stylet. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Residents in the department of Anesthesia and Pain Medicine
Key inclusion criteria (1 listed)
- residents in the department of Anesthesia and Pain Medicine
Key exclusion criteria (1 listed)
- refusal for participation
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 |
|---|---|---|
| hand positionFor tracheal intubation with a stylet for a manikin, one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the patient, while the assistant pulling back the stylet. | Procedure or surgery | in the air, on the cheek of a manikin |
Primary outcome
tube movement distance
Time frame: procedure (at the time when the assistant pulling back the stylet)
tube movement distance in the process of pulling out the stylet by the assistant
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 13 Sep 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.
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 Manikin, 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 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 13 Sep 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?
tube movement distance (time frame: procedure (at the time when the assistant pulling back the stylet)). 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 13 Sep 2023.