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Completed

NCT Number: NCT04087837

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

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bougie

Device

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

Nasogastric(NG) tube

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2019
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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