Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General AnesthesiaNCT04441970
The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube
A study testing Neutral position, Head extension position and Head flexion position in people with Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia
- What is being tested?
- Neutral position, Head extension position and Head flexion position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2020to Mar 2021
- 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
- Adult patients over 20 years of age
- patients who require intubation of the nasotracheal tube to undergo oral and maxillofacial surgery under general anesthesia
Who cannot join
- Patients whose neck cannot be rotated due to cervical diseases, cervical fractures, and previous cervical surgery
- Patients undergoing emergency surgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Hyun Joo Kim, 82-2-2224-1389, jjollong@yuhs.ac
About this study
Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. After the nasotracheal tube is placed in the patient's trachea, the process of inflating the cuff at the end of the tube with air is required. If the cuff is inflated with excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it is highly likely to cause ischemia. In addition, it was found that the pressure in the excessively inflated cuff was associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the patient's head and neck posture. The pressure changes in the cuff may vary depending on the material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head and neck posture on the pressure in the cuff of nasotracheal tube.
- Being tested
- Neutral position, Head extension position, Head flexion position, Head rotation position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral positionProcedure or surgery
The cuff pressure will be recorded at the neutral head position.
Head extension positionProcedure or surgery
The cuff pressure will be recorded at the head extension position.
Head flexion positionProcedure or surgery
The cuff pressure will be recorded at the head flexion position.
Head rotation positionProcedure or surgery
The cuff pressure will be recorded at the head rotation position.
| Study group | Role | What they receive |
|---|---|---|
| Neutral position | Active comparator | General anesthesia will be induced and nasotracheal tube will be placed through the patient's nose. After 30 seconds, the cuff pressure will be measured using a cuff manometer. Inspiratory tidal volume, expiratory tidal volume, peak inspiratory pressure, and end-tidal carbon dioxide waveform will be recorded three times according to breathing. Whether ventilation is not adequate and air is leaking will be recorded. Receives: Procedure: Neutral position |
| Head extension position | Experimental | After changing the posture of the head and neck into head extension, cuff pressure will be recorded. Receives: Procedure: Head extension position |
| Head flexion position | Experimental | After changing the posture of the head and neck into head flexion, cuff pressure will be recorded. Receives: Procedure: Head flexion position |
| Head rotation position | Experimental | After changing the posture of the head and neck into head rotation, cuff pressure will be recorded. Receives: Procedure: Head rotation position |
What is being measured
The primary outcome is the main question the study is designed to answer.
cuff pressure of the nasotracheal tube
Cuff pressure will be measured in the various head and neck positions.
Measured: for 10 minutes after intubating the nasotracheal tube. At Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start24 Jun 2020
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyun Joo Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441970
- Sponsor's protocol ID
- 4-2020-0442
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube
- ClinicalTrials.gov ID
- NCT04441970
- Acronym / sponsor ID
- 4-2020-0442
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 22 Jun 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.
Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. After the nasotracheal tube is placed in the patient's trachea, the process of inflating the cuff at the end of the tube with air is required. If the cuff is inflated with excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it is highly likely to cause ischemia. In addition, it was found that the pressure in the excessively inflated cuff was associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the patient's head and neck posture. The pressure changes in the cuff may vary depending on the material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head and neck posture on the pressure in the cuff of nasotracheal tube.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neutral position | Active comparator | Procedure: Neutral positionGeneral anesthesia will be induced and nasotracheal tube will be placed through the patient's nose. After 30 seconds, the cuff pressure will be measured using a cuff manometer. Inspiratory tidal volume, expiratory tidal volume, peak inspiratory pressure, and end-tidal carbon dioxide waveform will be recorded three times according to breathing. Whether ventilation is not adequate and air is leaking will be recorded. |
| Head extension position | Experimental | Procedure: Head extension positionAfter changing the posture of the head and neck into head extension, cuff pressure will be recorded. |
| Head flexion position | Experimental | Procedure: Head flexion positionAfter changing the posture of the head and neck into head flexion, cuff pressure will be recorded. |
| Head rotation position | Experimental | Procedure: Head rotation positionAfter changing the posture of the head and neck into head rotation, cuff pressure will be recorded. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over 20 years of age
- patients who require intubation of the nasotracheal tube to undergo oral and maxillofacial surgery under general anesthesia
Key exclusion criteria (3 listed)
- Patients whose neck cannot be rotated due to cervical diseases, cervical fractures, and previous cervical surgery
- Patients undergoing emergency surgery
- Pregnant women
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 |
|---|---|---|
| Neutral positionThe cuff pressure will be recorded at the neutral head position. | Procedure or surgery | Neutral position |
| Head extension positionThe cuff pressure will be recorded at the head extension position. | Procedure or surgery | Head extension position |
| Head flexion positionThe cuff pressure will be recorded at the head flexion position. | Procedure or surgery | Head flexion position |
| Head rotation positionThe cuff pressure will be recorded at the head rotation position. | Procedure or surgery | Head rotation position |
Primary outcome
cuff pressure of the nasotracheal tube
Time frame: for 10 minutes after intubating the nasotracheal tube. At Day 0.
Cuff pressure will be measured in the various head and neck positions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No
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.
Hyun Joo Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral position, Head extension position and Head flexion position in people with Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia, run by Yonsei University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Joo Kim (82-2-2224-1389, jjollong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cuff pressure of the nasotracheal tube (time frame: for 10 minutes after intubating the nasotracheal tube. At Day 0.). 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 23 Sep 2020.