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

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ClinicalTrials.gov Identifier: NCT04087837
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
KMUHIRB-F(I)-20190075, Kaohsiung Medical University Chung-Ho Memorial Hospital

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: bougie 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 : June 14, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. success rate of tube advancement and successful first tube attempt [ Time Frame: 10 minutes ]
    success rate of tube passing through nasal cavity into trachea

  2. time taken in tube advancement [ Time Frame: 10 minutes ]
    time taken in tube advancement from nostril into trachea in each time interval


Secondary Outcome Measures :
  1. post-intubation induced hoarseness and sore throat [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087837


Contacts
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Contact: Pin-Yang Hu, MD 88673121101 ext 7035 u8901090@gmail.com
Contact: Kuang-I Cheng, MD, PhD. 88673121101 ext 7035 kuaich@kmu.edu.tw

Locations
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Taiwan
Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Pin-Yang Hu, MD    88673121101 ext 7035    u8901090@gmail.com   
Contact: Kuang-I Cheng, MD,PhD    88673121101 ext 7035    kuaich@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

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Responsible Party: KMUHIRB-F(I)-20190075, physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04087837     History of Changes
Other Study ID Numbers: KMUHIRB-F(I)-20190075
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KMUHIRB-F(I)-20190075, Kaohsiung Medical University Chung-Ho Memorial Hospital:
bougie, nasotracheal tube
Endotracheal Tube intubation General Anesthesia (ETGA)