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Intubation, IntratrachealNTINCT05534451

Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.

A study testing video laryngoscope guided nasotracheal intubation, video rigid laryngoscope guided nasotracheal intubation and video fiberoptic scope guided nasotracheal intubation in people with Intubation, Intratracheal and Airway Management, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Nasotracheal intubation (NTI) has become the most optimal alternative to oral endotracheal intubation for oro-maxillofacial surgery because it can offer an excellent vision field of the mouth. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Intubation, Intratracheal, Airway Management
What is being tested?
video laryngoscope guided nasotracheal intubation, video rigid laryngoscope guided nasotracheal intubation and video fiberoptic scope guided nasotracheal intubation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Sep 2023to 31 Jul 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants scheduled for elective oro-maxillofacial surgery under general anesthesia.
  • Age between 18 and 65 years old.
  • The American Society of Anesthesiologists (ASA) Ⅰ~Ⅱ.
  • Body mass index (BMI) 18.5~24.9kg/m2.
  • Mallampati Ⅰ~Ⅱ.
  • Able to give informed consent.

Who cannot join

  • Participants with severe intranasal diseases.
  • Participants with severe and uncontrolled clotting diseases.
  • Participants with skull base fractures and cerebrospinal fluid leakage.
  • Participants with unstable cardiovascular and cerebrovascular diseases, or with poor tolerance to vagal stimulation.
  • Participants who are deemed ineligible for participation in the clinical trial by the investigator.
  • Participants who have to receive the alternative therapy to establish ventilation after the several attempts for nasotracheal intubation.

Trial locations and contacts

No sites are listed yet.

Zhilin Wu, MD, PhD. contact

18963946992

840916@qq.com

About this study

Official title: Comparison Among Three Different Video Scope Guided Nasotracheal Intubation: a Prospective, Non-randomised Controlled Trial

Nasotracheal intubation (NTI) has become the most optimal alternative to oral endotracheal intubation for oro-maxillofacial surgery because it can offer an excellent vision field of the mouth. Additional benefits include milder oropharynx stimulation, less airway secretions, and better tolerance for long term endotracheal intubation maintenance. Traditional NTI is performed under the guidance of indirect laryngoscope, which is often accompanied by longer maneuver time and adverse complications such as trauma and bleeding. The development of various visualization tools such as video laryngoscope, video fiberoptic scope and video rigid laryngoscope has greatly improved NTI. However, there is no consensus on which one is the best adjunctive device for NTI. Therefore, a study on a comparison of the clinical efficacy of the above three video scope guided methods for NTI will be conducted.

Read the detailed description

A total of 60 eligible patients will be enrolled in this prospective study, they are scheduled to undergo elective oro-maxillofacial surgeries under general anaesthesia with nasotracheal intubation in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. According to the kinds of video methods uesd to assist in nasotracheal intubation, patients will be randomly divided into video laryngoscope group, video fiberoptic scope group and video rigid laryngoscope group, 20 participants in each group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

Being tested
video laryngoscope guided nasotracheal intubation, video rigid laryngoscope guided nasotracheal intubation, video fiberoptic scope guided nasotracheal intubation
Keywords
nasotracheal intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video laryngoscope guided nasotracheal intubationBehavioural

    According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be divided into video laryngoscope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

  • video rigid laryngoscope guided nasotracheal intubationBehavioural

    According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be divided into video rigid laryngoscope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

  • video fiberoptic scope guided nasotracheal intubationBehavioural

    According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be randomly divided into video fiberoptic scope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

Study groups in NCT05534451
Study groupRoleWhat they receive
video rigid laryngoscope groupExperimentalSimilarly during intubation, the patient should be placed in the supine position with the neutral head. The endoscopic body of video rigid laryngoscope covered by a lubricated endotracheal tube enters the airway through the nasal cavity, then proceeds under visual conditions. When the epiglottis is exposed, if necessary, gently lift the patient's lower jaw so that the glottis is fully visible. The tube is pushed to approach and pass the glottis. Withdraw the endoscopic body while adjusting the depth of tube in the trachea. The intubation ends with tube fixation.
Receives: Behavioral: video rigid laryngoscope guided nasotracheal intubation
video laryngoscope groupExperimentalFirst of all, participants will be asked to take supine position with neutral head. The operator will insert a lubricated endotracheal tube through the nasal cavity into the oropharynx, while he/she holds the handle of video laryngoscope in his/her left hand. Laryngoscope blade can be placed into oral cavity along the right corner of the patient's mouth, and the tongue is pushed to the left by moving the handle. Blade should arrive at a suitable depth to fully expose the epiglottis and glottis. After that, the operator can push the catheter with the right hand to approach and pass the glottis, sometimes Magill forceps are necessary. Finally, the tube is inserted into the trachea to the appropriate depth and fixed firmly.
Receives: Behavioral: video laryngoscope guided nasotracheal intubation
video fiberoptic scope groupExperimentalIt is suggested to apply paraffin oil to the surface of the insertion tube of video fiberoptic scope, where the friction with the inner wall of the endotracheal catheter will be reduced. The insertion tube together with a lubricated endotracheal tube will be placed into the nasopharynx through the nasal cavity of patient who takes supine position with neutral head. Push the insertion tube slowly and continuously along the airway until cuff passes through the glottis. Next carefully, the endotracheal tube can be delivered into the trachea, and the insertion tube can be withdrawn from the trachea. At last, the tracheal catheter can be fixed after the depth is adjusted to an appropriate level.
Receives: Behavioral: video fiberoptic scope guided nasotracheal intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the duration of catheter reaching oropharynx

    time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the oropharynx

    Measured: within 1 minute

  2. the duration of catheter reaching glottis

    time requirements for the anterior segment of the endotracheal tube from being put into the nasal cavity to the glottis being exposed

    Measured: within 1 minute

  3. successful intubation time

    time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the trachea

    Measured: within 3 minute

  4. the first-attempt intubation success rate

    number of successful first-attempt intubation/total number of intubations

    Measured: anticipated eight months

  5. average number of intubations

    average number of nasotracheal intubations for each participant

    Measured: anticipated eight months

Secondary outcomes (5)
  1. the number of participants whose oral and nasal mucosa bleeds during intubation

    during nasotracheal intubation, whether airway soft tissue is damaged, such as bleeding

    Measured: within 3 minute

  2. the number of participants whose tracheal ring is pressed and catheter is rotated when intubation

    during nasotracheal intubation, record whether the operator presses the tracheal ring and rotates the tracheal tube to assist intubation

    Measured: within 3 minute

  3. Blood pressure values before and after intubation intubation

    record blood pressure values before and after intubation

    Measured: 20 minute

  4. Heart rate values before and after intubation intubation

    record heart rate before and after intubation

    Measured: 20 minute

  5. the occurrence of throat complications

    inquiry and record intubation related complications, such as sore throat and hoarseness

    Measured: within 2 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2022
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
According to the kinds of video methods uesd to assist in nasotracheal intubation, patients will be randomly divided into video laryngoscope group, video fiberoptic scope group and video rigid laryngoscope group, 20 participants in each group.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05534451
Sponsor's protocol ID
2022SY
Acronym
NTI
Status last verified
Aug 2023
First submitted
30 Aug 2022
Last updated
18 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park DH, Lee CA, Jeong CY, Yang HS. Nasotracheal intubation for airway management during anesthesia. Anesth Pain Med (Seoul). 2021 Jul;16(3):232-247. doi: 10.17085/apm.21040. Epub 2021 Jul 30.

    PubMed 34352965
  • Zhang J, Lamb A, Hung O, Hung C, Hung D. Blind nasal intubation: teaching a dying art. Can J Anaesth. 2014 Nov;61(11):1055-6. doi: 10.1007/s12630-014-0223-9. Epub 2014 Aug 15. No abstract available.

    PubMed 25125251
  • Gorback MS. Inflation of the endotracheal tube cuff as an aid to blind nasal endotracheal intubation. Anesth Analg. 1987 Sep;66(9):916-7. No abstract available.

    PubMed 3619105
  • Abdallah R, Galway U, You J, Kurz A, Sessler DI, Doyle DJ. A randomized comparison between the Pentax AWS video laryngoscope and the Macintosh laryngoscope in morbidly obese patients. Anesth Analg. 2011 Nov;113(5):1082-7. doi: 10.1213/ANE.0b013e31822cf47d. Epub 2011 Sep 14.

    PubMed 21918156
  • Tachibana N, Niiyama Y, Yamakage M. Less postoperative sore throat after nasotracheal intubation using a fiberoptic bronchoscope than using a Macintosh laryngoscope: A double-blind, randomized, controlled study. J Clin Anesth. 2017 Jun;39:113-117. doi: 10.1016/j.jclinane.2016.10.026. Epub 2017 Apr 6.

    PubMed 28494884
  • Enterlein G, Byhahn C; American Society of Anesthesiologists Task Force. [Practice guidelines for management of the difficult airway: update by the American Society of Anesthesiologists task force]. Anaesthesist. 2013 Oct;62(10):832-5. doi: 10.1007/s00101-013-2222-6. German.

    PubMed 24104949
  • Park EY, Kim JY, Lee JS. Tracheal intubation using the Airtraq: a comparison with the lightwand. Anaesthesia. 2010 Jul;65(7):729-32. doi: 10.1111/j.1365-2044.2010.06376.x. Epub 2010 May 17.

    PubMed 20497149

Questions about this trial

What is this clinical trial studying?

A study testing video laryngoscope guided nasotracheal intubation, video rigid laryngoscope guided nasotracheal intubation and video fiberoptic scope guided nasotracheal intubation in people with Intubation, Intratracheal and Airway Management, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 6 inclusion and 6 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 Zhilin Wu, MD, PhD. (18963946992, 840916@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the duration of catheter reaching oropharynx (time frame: within 1 minute). The study lists 5 primary outcomes in all. 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 NCT05534451, which also lists 7 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 18 Aug 2023.

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