Effect of Different Nasotracheal Tubes on Tube Passage

NCT ID: NCT04695444

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2022-11-04

Brief Summary

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The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.

Detailed Description

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The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.

Conditions

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Sialolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional PVC tube

When performing nasotracheal intubation, clinicians use the conventional PVC tube.

Group Type ACTIVE_COMPARATOR

nasotracheal tube (Ring-Adair-Elwin)

Intervention Type DEVICE

different materials for nasotracheal intubation conventional PVC tube

PVC tube with rubber suction catheter

When performing nasotracheal intubation, clinicians use the conventional PVC tube + rubber suction catheter.

Group Type EXPERIMENTAL

nasotracheal tube (Ring-Adair-Elwin)

Intervention Type DEVICE

different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter

velvet soft PVC tube

When performing nasotracheal intubation, clinicians use the velvet soft PVC tube.

Group Type EXPERIMENTAL

nasotracheal tube (portex)

Intervention Type DEVICE

different materials for nasotracheal intubation velvet soft PVC tube.

Interventions

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nasotracheal tube (Ring-Adair-Elwin)

different materials for nasotracheal intubation conventional PVC tube

Intervention Type DEVICE

nasotracheal tube (Ring-Adair-Elwin)

different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter

Intervention Type DEVICE

nasotracheal tube (portex)

different materials for nasotracheal intubation velvet soft PVC tube.

Intervention Type DEVICE

Other Intervention Names

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nasal RAE (Ring-Adair-Elwin) tube nasal RAE (Ring-Adair-Elwin) tube portex tube

Eligibility Criteria

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Inclusion Criteria

* The patients who need to nasotracheal intubation for surgery
* age: 19 years old or more

Exclusion Criteria

* patient refusal
* nasal deformity
* history of previous moderate degree of epistaxis
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul Ho Chang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chul Ho Chnag

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.

Reference Type BACKGROUND
PMID: 31421677 (View on PubMed)

Lee J, Lee JM, Shim YH, Cho JG, Lee J, Lim JY, Chang CH. A randomized comparison of three intubation techniques/tube materials for nasotracheal intubation. Can J Anaesth. 2024 Jul;71(7):978-986. doi: 10.1007/s12630-024-02743-z. Epub 2024 Mar 28.

Reference Type DERIVED
PMID: 38548948 (View on PubMed)

Other Identifiers

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3-2020-0444

Identifier Type: -

Identifier Source: org_study_id

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