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Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation

Primary Purpose

Nasotracheal Intubation

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

rhinoscope

About this trial

This is an interventional diagnostic trial for Nasotracheal Intubation focused on measuring epistaxis, rhinoscope

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I or II undergoing surgery under nasotracheal intubation

Exclusion Criteria:

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

Sites / Locations

Ajou universitiy school of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

rhinoscope group

Arm Description

nose selection will be done by random table

nose selection will be done by rhinoscopy

Outcomes

Primary Outcome Measures

incidence of epistaxis

percentage of the development of epistaxis after nasotracheal intubation

incidence of epistaxis

percentage of the development of epistaxis after nasotracheal intubation

Secondary Outcome Measures

severity of epistaxis4. severe: interfere intubation by blood

score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx

severity of epistaxis

score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx

Full Information

NCT ID

NCT04164836

First Posted

November 12, 2019

Last Updated

July 24, 2022

Sponsor

Ajou University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04164836

Brief Title

Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation

Official Title

The Effect of Suitable Nose Selection Using Rhinoscope on the Incidence and Severity of Epistaxis After Nasotracheal Intubation.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

November 26, 2019 (Actual)

Primary Completion Date

March 30, 2022 (Actual)

Study Completion Date

March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In addition, even when there are no structural abnormalities in the nasal cavity, the wider nasal cavity can be intuitively identified. This information is expected to assist in the selection of nostrils. It has not yet been studied whether anesthesiologists select nasal cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis. The purpose of this study is to determine whether the selection of a nostril for nasotracheal intubation by rhinoscope affects the incidence and severity of epistaxis.

6. Conditions and Keywords

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

Nasotracheal Intubation

Keywords

epistaxis, rhinoscope

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

nose selection will be done by random table

Arm Title

rhinoscope group

Arm Type

Experimental

Arm Description

nose selection will be done by rhinoscopy

Intervention Type

Diagnostic Test

Intervention Name(s)

rhinoscope

Intervention Description

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

Primary Outcome Measure Information:

Title

incidence of epistaxis

Description

percentage of the development of epistaxis after nasotracheal intubation

Time Frame

immediate after intubation

Title

incidence of epistaxis

Description

percentage of the development of epistaxis after nasotracheal intubation

Time Frame

5 min after intubation

Secondary Outcome Measure Information:

Title

severity of epistaxis4. severe: interfere intubation by blood

Description

score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx

Time Frame

immediate after intubation

Title

severity of epistaxis

Description

score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx

Time Frame

5 min after intubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I or II undergoing surgery under nasotracheal intubation Exclusion Criteria: expected difficult intubation based on history, physical examination, weight. bleeding tendency past history of nasal surgery symptom of difficulty of nasal respiration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yun jeong chae, PhD MD

Organizational Affiliation

Ajou University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ajou universitiy school of medicine

City

Suwon-si

State/Province

Gyeong-gi Do

ZIP/Postal Code

16499

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We will share data when reasonable personal request exist.

Learn more about this trial

Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation

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