The Effectiveness of Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Intubation

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04087837

Collaborator

(none)

Enrollment

Location

Arms

18.6

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	Device: bougie Device: Nasogastric(NG) tube	N/A

Detailed Description

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. In addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique.

The aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea.

Patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using Magill Forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

bougie or nasogastric tubebougie or nasogastric tube

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope

Actual Study Start Date :

Jun 14, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bougie group The bougie group: The end of the endotracheal tube was guided to the glottis using the endotracheal tube in the bougie mode under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.	Device: bougie The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.
Experimental: Nasogastric(NG) tube group NG tube group: The end of the endotracheal tube is guided to the glottis by using the endotracheal tube in the nasogastric tube under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.	Device: Nasogastric(NG) tube The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.
No Intervention: control group Control group: The general anesthesia method of placing the endotracheal tube through the nasal cavity is used to guide the tip of the endotracheal tube to the glottis under the direct view of the electronic imaging laryngoscope.

Arm

Intervention/Treatment

Experimental: bougie group

The bougie group: The end of the endotracheal tube was guided to the glottis using the endotracheal tube in the bougie mode under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

Device: bougie

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

Experimental: Nasogastric(NG) tube group

NG tube group: The end of the endotracheal tube is guided to the glottis by using the endotracheal tube in the nasogastric tube under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

Device: Nasogastric(NG) tube

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

No Intervention: control group

Control group: The general anesthesia method of placing the endotracheal tube through the nasal cavity is used to guide the tip of the endotracheal tube to the glottis under the direct view of the electronic imaging laryngoscope.

Outcome Measures

Primary Outcome Measures

success rate of tube advancement and successful first tube attempt [10 minutes]
success rate of tube passing through nasal cavity into trachea
time taken in tube advancement [10 minutes]
time taken in tube advancement from nostril into trachea in each time interval

Secondary Outcome Measures

post-intubation induced hoarseness and sore throat [2 days]
A visiting questionnaire is used to measure the condition of post-intubation, including sore throat, hoarseness, dysphagia, nasal occlusion, nosebleed and nasal pain. The score for the measurement of sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe; on the other hand, The score for the measurement of nasal occlusion, nosebleed and nasal pain is divided into yes or no. All the evaluation will be assessed in the next coming morning after the postoperation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pin-Yang Hu, MD, physician, Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT04087837

Other Study ID Numbers:

KMUHIRB-F(I)-20190075

First Posted:

Sep 12, 2019

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pin-Yang Hu, MD, physician, Kaohsiung Medical University Chung-Ho Memorial Hospital

bougie, nasotracheal tube

Endotracheal Tube intubation General Anesthesia (ETGA)

Study Results

No Results Posted as of Jan 12, 2021