Intubation ComplicationNCT05112783
Nasal Intubation：a Comparison of Different Endotracheal Tubes
A study testing Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal Tubes in people with Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal Tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jul 2021to 31 Dec 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:20-65 years
- Undergoing oro-maxillofacial surgery
- Opening mouth > 3 cm
- Denied any systemic disease.
- American Society of Anesthesiologists (ASA) class:I-III
Who cannot join
- Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm)
- Previous head and neck surgery history
- Upper abnormal airway diagnosed
- Easily epistaxis
- Both sides nasal cavities obstruction
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin District, 807
Pin-Yang Hu, MD, 88673121101 ext. 7035, u8901090@gmail.com
Kuang-I Cheng, PhD, 88673121101 ext. 7035, kuaich@kmu.edu.tw
About this study
Official title: Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope
Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.
Read the detailed description
- Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
- Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
- Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
- Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
- Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
- Anesthesia intubation inducer：Propofol 1mg/kg
- Intubation
- Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
- Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
- Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.
- Conditions
- Intubation Complication
- Being tested
- Henan Tuoren Endotracheal Tube, Smiths Portex Tracheal Tubes
- Keywords
- Endotracheal Tube intubation General Anesthesia (ETGA), nasotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henan Tuoren Endotracheal TubeDevice
The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.
Smiths Portex Tracheal TubesDevice
The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Henan Tuoren Endotracheal Tube group | Experimental | Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea Receives: Device: Henan Tuoren Endotracheal Tube |
| Smiths Portex Tracheal tubes group | Experimental | Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea Receives: Device: Smiths Portex Tracheal Tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea
Measured: 10 minutes
time
time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval
Measured: 10 minutes
Secondary outcomes (1)
post-anesthesia care
post-intubation induced hoarseness and sore throat intubation related hoarseness and sorethroat at post-anesthesia care unit and the next coming morning
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start16 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin-Yang Hu, MD, Principal investigator, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112783
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210124
- Status last verified
- Jul 2023
- First submitted
- 28 Oct 2021
- Last updated
- 15 Dec 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope
- ClinicalTrials.gov ID
- NCT05112783
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210124
- Conditions
- Intubation Complication
- Keywords
- Endotracheal Tube intubation General Anesthesia (ETGA), nasotracheal tube
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 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.
Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.
Detailed description
- Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
- Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
- Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
- Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
- Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
- Anesthesia intubation inducer：Propofol 1mg/kg
- Intubation
- Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
- Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
- Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Henan Tuoren Endotracheal Tube group | Experimental | Device: Henan Tuoren Endotracheal TubeUses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea |
| Smiths Portex Tracheal tubes group | Experimental | Device: Smiths Portex Tracheal TubesUses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:20-65 years
- Undergoing oro-maxillofacial surgery
- Opening mouth > 3 cm
- Denied any systemic disease.
- American Society of Anesthesiologists (ASA) class:I-III
Key exclusion criteria (5 listed)
- Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm)
- Previous head and neck surgery history
- Upper abnormal airway diagnosed
- Easily epistaxis
- Both sides nasal cavities obstruction
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 |
|---|---|---|
| Henan Tuoren Endotracheal TubeThe endotracheal tube is used under the direct view of the electronic imaging laryngoscope. | Device | Henan Tuoren Endotracheal Tube group |
| Smiths Portex Tracheal TubesThe endotracheal tube is used under the direct view of the electronic imaging laryngoscope. | Device | Smiths Portex Tracheal tubes group |
Primary outcome
success rate
Time frame: 10 minutes
success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea
time
Time frame: 10 minutes
time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval
1 secondary outcome
post-anesthesia care
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Pin-Yang Hu, MD principal investigator
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial 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 Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal Tubes in people with Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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 15 Dec 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 Taiwan. 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 Pin-Yang Hu, MD (88673121101 ext. 7035, u8901090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 15 Dec 2023.