Nasal Intubation:a Comparison of Different Endotracheal Tubes

NCT ID: NCT05112783

Last Updated: 2023-12-15

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

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2023-12-31

Brief Summary

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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

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1. Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
2. Randomly divided into two groups:Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
3. Sedation process:Give Fentanyl 1 ug/kg according to the patient's weight via IV.
4. Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
5. Sedative injection:give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
6. Anesthesia intubation inducer:Propofol 1mg/kg
7. Intubation
8. Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
9. Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
10. Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.

Conditions

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Intubation Complication

Keywords

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Endotracheal Tube intubation General Anesthesia (ETGA) nasotracheal tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Henan Tuoren Endotracheal Tube group

Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Group Type EXPERIMENTAL

Henan Tuoren Endotracheal Tube

Intervention Type DEVICE

The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

Smiths Portex Tracheal tubes group

Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Group Type EXPERIMENTAL

Smiths Portex Tracheal Tubes

Intervention Type DEVICE

The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

Interventions

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Henan Tuoren Endotracheal Tube

The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

Intervention Type DEVICE

Smiths Portex Tracheal Tubes

The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age:20-65 years
* Undergoing oro-maxillofacial surgery
* Opening mouth \> 3 cm
* Denied any systemic disease.
* American Society of Anesthesiologists (ASA) class:I-III

Exclusion Criteria

* 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
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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Responsibility Role SPONSOR

Principal Investigators

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Pin-Yang Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, 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

Phone: 88673121101

Email: [email protected]

Kuang-I Cheng, PhD

Role: CONTACT

Phone: 88673121101

Email: [email protected]

Facility Contacts

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Pin-Yang Hu, MD

Role: primary

Kuang-I Cheng, PhD

Role: backup

Other Identifiers

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KMUHIRB-F(I)-20210124

Identifier Type: -

Identifier Source: org_study_id