NCT04164836

Brief Summary

Rhinoscope is useful to exam intranasal structure. This information could be utilized to select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more patent nose could be associated with decrease of the development of epistaxis which is most common complication in nasotracheal intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

November 26, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

November 12, 2019

Last Update Submit

July 24, 2022

Conditions

Keywords

epistaxisrhinoscope

Outcome Measures

Primary Outcomes (2)

  • incidence of epistaxis

    percentage of the development of epistaxis after nasotracheal intubation

    immediate after intubation

  • incidence of epistaxis

    percentage of the development of epistaxis after nasotracheal intubation

    5 min after intubation

Secondary Outcomes (2)

  • severity of epistaxis4. severe: interfere intubation by blood

    immediate after intubation

  • severity of epistaxis

    5 min after intubation

Study Arms (2)

control group

NO INTERVENTION

nose selection will be done by random table

rhinoscope group

EXPERIMENTAL

nose selection will be done by rhinoscopy

Diagnostic Test: rhinoscope

Interventions

rhinoscopeDIAGNOSTIC_TEST

more suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope.

rhinoscope group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II undergoing surgery under nasotracheal intubation

You may not qualify if:

  • expected difficult intubation based on history, physical examination, weight.
  • bleeding tendency
  • past history of nasal surgery
  • symptom of difficulty of nasal respiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • yun jeong chae, PhD MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

November 26, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We will share data when reasonable personal request exist.

Locations