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CompletedNCT04459481Updated Jan 15, 2021

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

An interventional study of bending angle in Intubation;Difficult, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intubation;Difficult

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients require nasotracheal intubation

Exclusion criteria

Exclusion Criteria:

  • fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    70-degree bending angle group

    intubation with a 70-degree bending angle

    Device: bending angle

  • Experimental
    90-degree bending angle group

    intubation with a 90-degree bending angle

    Device: bending angle

Interventions

  • Devicebending 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

05

What researchers measure

Primary outcomes

  1. Success rate of nasotracheal intubation

    The percentage of successful nasotracheal intubation

    Time frame: Procedure (From the beginning of intubation to the end of intubation)

06

Study locations

1 site
  • ChineseAMS
    Beijing, Beijing 100144, China
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04459481
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Juhui Liu (Plastic Surgery Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jul 7, 2020
Start date
Jun 4, 2020
Primary completion
Nov 3, 2020
Completion
Nov 5, 2020
Last update
Jan 15, 2021

Study contacts

Xiaoming Deng, MD
principal investigator · Chinese Academy of Medical Sciences and Peking Union Medical College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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