Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

NCT ID: NCT04749225

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-11

Study Completion Date

2023-12-31

Brief Summary

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Uses the video stylet with different angulation to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea.

Detailed Description

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In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the nasotracheal tube passing the nasal cavity, oropharynx, and advanced into the tracheal. Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate nasotracheal tube sliding through into trachea and compared with each other group.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea will be recorded. The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Conditions

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Intubation Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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45° group

Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

70° group

Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

90° group

Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* undergoing oro-maxillofacial surgery with general anesthesia(GA)
* ASA(American Society of Anesthesiologists):Ι to III
* 20-65 y/o
* mouth Open \> 3cm
* the systemic disease exclusion
* conscious clear and without major Neurocognitive Disorder
* Mandarin or Taiwanese speaker
* agree the purpose of the study and sign the ICF

Exclusion Criteria

* difficult airway assessment \[limited mouth opening\<3cm, limited neck motion(thyromental distance \< 6cm\]
* previous head neck surgery history
* upper abnormal airway diagnosed, easily epistaxis, and both sides nasal cavities obstruction.
* reject to participate
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pin-Yang Hu, MD

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pin-Yang Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pin-Yang Hu, MD.

Role: CONTACT

88673121101 ext. 7035

Kuang-I Cheng, MD, PhD

Role: CONTACT

88673121101 ext. 7035

Facility Contacts

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Pin-Yang Hu, MD

Role: primary

88673121101 ext. 7035

Other Identifiers

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KMUHIRB-F(I)-20200202

Identifier Type: -

Identifier Source: org_study_id

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