Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet

Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100144
        • ChineseAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients require nasotracheal intubation

Exclusion Criteria:

  • fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 70-degree bending angle group
intubation with a 70-degree bending angle
patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
Experimental: 90-degree bending angle group
intubation with a 90-degree bending angle
patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of nasotracheal intubation
Time Frame: Procedure (From the beginning of intubation to the end of intubation)
The percentage of successful nasotracheal intubation
Procedure (From the beginning of intubation to the end of intubation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiaoming Deng, MD, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2020

Primary Completion (Actual)

November 3, 2020

Study Completion (Actual)

November 5, 2020

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSH-2018-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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