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
|Condition or disease||Intervention/treatment||Phase|
|Intubation Complication||Device: bougie Device: Nasogastric(NG) tube||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||bougie or nasogastric tube|
|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|
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.
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.
- success rate of tube advancement and successful first tube attempt [ Time Frame: 10 minutes ]success rate of tube passing through nasal cavity into trachea
- time taken in tube advancement [ Time Frame: 10 minutes ]time taken in tube advancement from nostril into trachea in each time interval
- 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.
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
|Contact: Pin-Yang Hu, MD||88673121101 ext email@example.com|
|Contact: Kuang-I Cheng, MD, PhD.||88673121101 ext firstname.lastname@example.org|
|Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital||Recruiting|
|Kaohsiung, Taiwan, 807|
|Contact: Pin-Yang Hu, MD 88673121101 ext 7035 email@example.com|
|Contact: Kuang-I Cheng, MD,PhD 88673121101 ext 7035 firstname.lastname@example.org|