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

Primary Purpose

Intubation;Difficult

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bending angle
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intubation;Difficult

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ChineseAMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

70-degree bending angle group

90-degree bending angle group

Arm Description

intubation with a 70-degree bending angle

intubation with a 90-degree bending angle

Outcomes

Primary Outcome Measures

Success rate of nasotracheal intubation
The percentage of successful nasotracheal intubation

Secondary Outcome Measures

Full Information

First Posted
July 2, 2020
Last Updated
January 13, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04459481
Brief Title
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
Official Title
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation;Difficult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
70-degree bending angle group
Arm Type
Experimental
Arm Description
intubation with a 70-degree bending angle
Arm Title
90-degree bending angle group
Arm Type
Experimental
Arm Description
intubation with a 90-degree bending angle
Intervention Type
Device
Intervention Name(s)
bending angle
Intervention Description
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
Primary Outcome Measure Information:
Title
Success rate of nasotracheal intubation
Description
The percentage of successful nasotracheal intubation
Time Frame
Procedure (From the beginning of intubation to the end of intubation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Deng, MD
Organizational Affiliation
Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChineseAMS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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