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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087837
• Other study ID #: KMUHIRB-F(I)-20190075
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• bougie
The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.
• Nasogastric(NG) tube
The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.

Locations

Country	Name	City	State
Taiwan	Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of tube advancement and successful first tube attempt	success rate of tube passing through nasal cavity into trachea	10 minutes
Primary	time taken in tube advancement	time taken in tube advancement from nostril into trachea in each time interval	10 minutes
Secondary	post-intubation induced hoarseness and sore throat	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.	2 days