IntubationNCT05164276
Head Position on Pediatric Nasotracheal Intubation
A study testing Head position in people with Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Intubation
- What is being tested?
- Head position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 May 2022to 6 Sep 2023
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-8 years old
- Amerian Society of Anesthesiologists I or II
- Patients who need nasotracheal intubation for surgery
Who cannot join
- A recent airway infection within 14 days
- Anatomical deformity in head and neck
- Modified Mallampati score IV
- Bleeding tendency in preoperative laboratory examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Head Position on Nasotracheal Intubation With Video-laryngoscope in Pediatric Patients: A Randomized Controlled Trial
The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope.
- Conditions
- Intubation
- Being tested
- Head position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head positionOther
Before nasotracheal intubation, patient's head is positioned to one of three positions according to assigned group: sniffing, neutral or flexed position.
| Study group | Role | What they receive |
|---|---|---|
| Sniffing group | Active comparator | Before intubation, the patient's shoulder is supported by a 5cm pillow to make neck flexion with extension of atlanto-occipital joint, confirming that the external auditory meatus and sternal notch plane are horizontal and aligned. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). Receives: Other: Head position |
| Neutral group | Experimental | Before intubation, the patient's head is placed without a pillow on the bed. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). Receives: Other: Head position |
| Flexed group | Experimental | Before intubation, the patient's neck is flexed with pads until the chin touches the chest. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). Receives: Other: Head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
The time between entry of the nasotracheal tube into a nostril and appearance of a carbon dioxide wave on the monitor.
Measured: Within 5 minutes
Secondary outcomes (3)
Intubation difficulty scale
The sum of score from seven variables including intubation attempts, supplementary operators, the use of alternative techniques, glottic exposure, the lifting force applied during laryngoscopy, the necessity of applied external laryngeal pressure, and position of vocal cords.
From 0 (easiest) to 8 (most difficult)
Measured: During intubation
Epistaxis score
grade 1 (no-epistaxis), grade 2 (mild, blood on the tube only), grade 3 (moderate, blood pooling in the pharynx), or grade 4 (severe: blood impedes intubation)
Measured: When removing the video-laryngoscope
Numeric rating scale of intubation difficulty
Subjective intubation difficulty from 0 (easiest) to 10 (most difficult)
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start18 May 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164276
- Sponsor's protocol ID
- AJIRB-MED-INT-21-432
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2021
- Last updated
- 25 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Position on Nasotracheal Intubation With Video-laryngoscope in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05164276
- Acronym / sponsor ID
- AJIRB-MED-INT-21-432
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 20 Dec 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.
The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sniffing group | Active comparator | Other: Head positionBefore intubation, the patient's shoulder is supported by a 5cm pillow to make neck flexion with extension of atlanto-occipital joint, confirming that the external auditory meatus and sternal notch plane are horizontal and aligned. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). |
| Neutral group | Experimental | Other: Head positionBefore intubation, the patient's head is placed without a pillow on the bed. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). |
| Flexed group | Experimental | Other: Head positionBefore intubation, the patient's neck is flexed with pads until the chin touches the chest. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea). |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 2-8 years old
- Amerian Society of Anesthesiologists I or II
- Patients who need nasotracheal intubation for surgery
Key exclusion criteria (4 listed)
- A recent airway infection within 14 days
- Anatomical deformity in head and neck
- Modified Mallampati score IV
- Bleeding tendency in preoperative laboratory examination
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 |
|---|---|---|
| Head positionBefore nasotracheal intubation, patient's head is positioned to one of three positions according to assigned group: sniffing, neutral or flexed position. | Other | Flexed group, Neutral group, Sniffing group |
Primary outcome
Intubation time
Time frame: Within 5 minutes
The time between entry of the nasotracheal tube into a nostril and appearance of a carbon dioxide wave on the monitor.
3 secondary outcomes
Intubation difficulty scale
Time frame: During intubation
Epistaxis score
Time frame: When removing the video-laryngoscope
Numeric rating scale of intubation difficulty
Time frame: During 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 25 Jul 2024.
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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?
A study testing Head position in people with Intubation, 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 Jul 2024. 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 Jul 2024.