SialolithiasisNCT04695444
Effect of Different Nasotracheal Tubes on Tube Passage
A study testing nasotracheal tube (Ring-Adair-Elwin) and nasotracheal tube (portex) in people with Sialolithiasis, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sialolithiasis
- What is being tested?
- nasotracheal tube (Ring-Adair-Elwin) and nasotracheal tube (portex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2021to 4 Nov 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
- The patients who need to nasotracheal intubation for surgery
- age: 19 years old or more
Who cannot join
- patient refusal
- nasal deformity
- history of previous moderate degree of epistaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Tube Type and Intubation Technique on Nasopharyngeal Passage During Nasotracheal Intubation
The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.
Read the detailed description
The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.
- Conditions
- Sialolithiasis
- Being tested
- nasotracheal tube (Ring-Adair-Elwin), nasotracheal tube (portex)
- Keywords
- nasotracheal intubation
- Medical subject headings
- Salivary Gland Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasotracheal tube (Ring-Adair-Elwin)Device
Also called nasal RAE (Ring-Adair-Elwin) tube
different materials for nasotracheal intubation conventional PVC tube
nasotracheal tube (Ring-Adair-Elwin)Device
Also called nasal RAE (Ring-Adair-Elwin) tube
different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter
nasotracheal tube (portex)Device
Also called portex tube
different materials for nasotracheal intubation velvet soft PVC tube.
| Study group | Role | What they receive |
|---|---|---|
| conventional PVC tube | Active comparator | When performing nasotracheal intubation, clinicians use the conventional PVC tube. Receives: Device: nasotracheal tube (Ring-Adair-Elwin) |
| PVC tube with rubber suction catheter | Experimental | When performing nasotracheal intubation, clinicians use the conventional PVC tube + rubber suction catheter. Receives: Device: nasotracheal tube (Ring-Adair-Elwin) |
| velvet soft PVC tube | Experimental | When performing nasotracheal intubation, clinicians use the velvet soft PVC tube. Receives: Device: nasotracheal tube (portex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blockade of tube advancement from the nasal cavity to the oral cavity [ during intubation]
When entering a nasotracheal tube from the nasal cavity to the oral cavity before use of laryngoscope in nasotracheal intubation, clinicians sometimes encounter blockade of in tube advancement. The reason is that the direction of the nasotracheal tube and the posterior wall of the nasopharynx are anatomically perpendicular. When advancing the tube from the nasal cavity to the oral cavity, the researcher will evaluate the presence of blockade of tube advancement in the pharynx. (none / present)
Measured: During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the intubation )
Secondary outcomes (1)
Intubation time
the total time of nasotracheal intubation: From the time of insertion of the tube or tube combined with the rubber suction to the completion of nasotracheal intubation
Measured: During nasotracheal intubation (From the time of insertion of the tube or tube combined with the rubber suction catheter to the completion of nasotracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start8 Jan 2021
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SialolithiasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul Ho Chang, Gangnam Severance Hospital
- Investigators
- Chul Ho Chnag, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695444
- Sponsor's protocol ID
- 3-2020-0444
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2020
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.
PubMed 31421677Lee J, Lee JM, Shim YH, Cho JG, Lee J, Lim JY, Chang CH. A randomized comparison of three intubation techniques/tube materials for nasotracheal intubation. Can J Anaesth. 2024 Jul;71(7):978-986. doi: 10.1007/s12630-024-02743-z. Epub 2024 Mar 28.
PubMed 38548948
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Tube Type and Intubation Technique on Nasopharyngeal Passage During Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT04695444
- Acronym / sponsor ID
- 3-2020-0444
- Conditions
- Sialolithiasis
- Keywords
- nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 5 Jan 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 purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.
Detailed description
The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional PVC tube | Active comparator | Device: nasotracheal tube (Ring-Adair-Elwin)When performing nasotracheal intubation, clinicians use the conventional PVC tube. |
| PVC tube with rubber suction catheter | Experimental | Device: nasotracheal tube (Ring-Adair-Elwin)When performing nasotracheal intubation, clinicians use the conventional PVC tube + rubber suction catheter. |
| velvet soft PVC tube | Experimental | Device: nasotracheal tube (portex)When performing nasotracheal intubation, clinicians use the velvet soft PVC tube. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients who need to nasotracheal intubation for surgery
- age: 19 years old or more
Key exclusion criteria (3 listed)
- patient refusal
- nasal deformity
- history of previous moderate degree of epistaxis
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 |
|---|---|---|
| nasotracheal tube (Ring-Adair-Elwin)Also: nasal RAE (Ring-Adair-Elwin) tubedifferent materials for nasotracheal intubation conventional PVC tube | Device | conventional PVC tube |
| nasotracheal tube (Ring-Adair-Elwin)Also: nasal RAE (Ring-Adair-Elwin) tubedifferent materials for nasotracheal intubation conventional PVC tube with rubber suction catheter | Device | PVC tube with rubber suction catheter |
| nasotracheal tube (portex)Also: portex tubedifferent materials for nasotracheal intubation velvet soft PVC tube. | Device | velvet soft PVC tube |
Primary outcome
blockade of tube advancement from the nasal cavity to the oral cavity [ during intubation]
Time frame: During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the intubation )
When entering a nasotracheal tube from the nasal cavity to the oral cavity before use of laryngoscope in nasotracheal intubation, clinicians sometimes encounter blockade of in tube advancement. The reason is that the direction of the nasotracheal tube and the posterior wall of the nasopharynx are anatomically perpendicular. When advancing the tube from the nasal cavity to the oral cavity, the researcher will evaluate the presence of blockade of tube advancement in the pharynx. (none / present)
1 secondary outcome
Intubation time
Time frame: During nasotracheal intubation (From the time of insertion of the tube or tube combined with the rubber suction catheter to the completion of nasotracheal 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 5 Dec 2022.
- Background: PubMed 31421677Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.
- Derived from this study: PubMed 38548948Lee J, Lee JM, Shim YH, Cho JG, Lee J, Lim JY, Chang CH. A randomized comparison of three intubation techniques/tube materials for nasotracheal intubation. Can J Anaesth. 2024 Jul;71(7):978-986. doi: 10.1007/s12630-024-02743-z. Epub 2024 Mar 28.
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.
Chul Ho Chnag principal investigator
Gangnam 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 nasotracheal tube (Ring-Adair-Elwin) and nasotracheal tube (portex) in people with Sialolithiasis, run by Gangnam Severance 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 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: finished, as of the sponsor's last update on 5 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?
blockade of tube advancement from the nasal cavity to the oral cavity [ during intubation] (time frame: During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the 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 NCT04695444, which also lists 2 linked publications.
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 5 Dec 2022.