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The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube

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ClinicalTrials.gov Identifier: NCT03740620
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Tae Kyong Kim, Seoul National University Hospital

Brief Summary:
In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

Condition or disease Intervention/treatment Phase
Epistaxis Intubation Complication Procedure: Bevel facing the cephalad direction of the patient Procedure: Bevel facing leftward of the patient Not Applicable

Detailed Description:

Primary outcome

  • incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) Secondary outcome
  • intubation time
  • incidence of epistaxis
  • severity of bleeding
  • Resistance during Insertion of the tracheal tube

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : October 26, 2019
Estimated Study Completion Date : October 26, 2019

Arm Intervention/treatment
Active Comparator: intervention group
In the intervention group, a nasotracheal tube is inserted into the nostril with the bevel of the tube facing the cephalad direction of the patient.
Procedure: Bevel facing the cephalad direction of the patient
The bevel of the nasotracheal tube facing cephalad direction of the patient

Active Comparator: conventional group
In the conventional group, a nasotracheal tube is inserted in a usual way, i.e., with the bevel of the tube facing the left side of the patient.
Procedure: Bevel facing leftward of the patient
The bevel of the nasotracheal tube facing the left side of the patient




Primary Outcome Measures :
  1. incidence of the tube in lower pathway [ Time Frame: right after completion of the intubation ]
    incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril)


Secondary Outcome Measures :
  1. intubation time [ Time Frame: from the start of the intubation to the completion of the intubation, which is confirmed by the appearance of end-tidal CO2 curve, up to 60 seconds ]
    time to complete endotracheal intubation

  2. incidence and severity of epistaxis [ Time Frame: right after completion of the intubation ]
    incidence and severity of epistaxis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a patient who will take operation which needs nasotracheal intubation under general anesthesia

Exclusion Criteria:

  • a patient who didn't agree to participate in this study
  • a patient who has a deformity of the nose
  • a patient who has a history of severe epistaxis
  • a patient who has coagulation problem
  • a patient who has a history of the fracture or surgery of the skull base

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): NCT03740620


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 07061
Contact: Tae Kyong Kim, MD    82-10-3750-5193    ktkktk@gmail.com   
Contact: Dong Wook Won, MD    82-10-3194-9471    won2501@naver.com   
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Tae Kyong Kim, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03740620     History of Changes
Other Study ID Numbers: 30-2018-76
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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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 Tae Kyong Kim, Seoul National University Hospital:
epistaxis

Additional relevant MeSH terms:
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Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms