NCT04459481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

July 2, 2020

Last Update Submit

January 13, 2021

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • Success rate of nasotracheal intubation

    The percentage of successful nasotracheal intubation

    Procedure (From the beginning of intubation to the end of intubation)

Study Arms (2)

70-degree bending angle group

EXPERIMENTAL

intubation with a 70-degree bending angle

Device: bending angle

90-degree bending angle group

EXPERIMENTAL

intubation with a 90-degree bending angle

Device: bending angle

Interventions

bending angleDEVICE

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

70-degree bending angle group90-degree bending angle group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients require nasotracheal intubation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChineseAMS

Beijing, Beijing Municipality, 100144, China

Location

Related Publications (1)

  • Liu J, Xu W, Jin Z, Deng X. Does Increasing the Bend Angle of a Stylet to 90 degrees Increase the Nasotracheal Intubation Success Rate? J Oral Maxillofac Surg. 2024 Feb;82(2):152-158. doi: 10.1016/j.joms.2023.10.005. Epub 2023 Oct 19.

    PMID: 37926429DERIVED

Study Officials

  • Xiaoming Deng, MD

    Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgery Hospital

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

June 4, 2020

Primary Completion

November 3, 2020

Study Completion

November 5, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)