Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740620
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Tae Kyong Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 2, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE January 14, 2019
Estimated Primary Completion Date January 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2018)
  • 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
  • incidence and severity of epistaxis [ Time Frame: right after completion of the intubation ]
    incidence and severity of epistaxis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube
Official Title  ICMJE The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Epistaxis
  • Intubation Complication
Intervention  ICMJE
  • Procedure: Bevel facing the cephalad direction of the patient
    The bevel of the nasotracheal tube facing cephalad direction of the patient
  • Procedure: Bevel facing leftward of the patient
    The bevel of the nasotracheal tube facing the left side of the patient
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Bevel facing the 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.
    Intervention: Procedure: Bevel facing leftward of the patient
Publications * Won D, Kim H, Chang JE, Lee JM, Min SW, Jung J, Yang HJ, Hwang JY, Kim TK. Effect of bevel direction on the tracheal tube pathway during nasotracheal intubation: A randomised trial. Eur J Anaesthesiol. 2020 Oct 1. doi: 10.1097/EJA.0000000000001347. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 26, 2020
Estimated Primary Completion Date January 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740620
Other Study ID Numbers  ICMJE 30-2018-76
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tae Kyong Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP