Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube

NCT ID: NCT04503031

Last Updated: 2020-10-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endotracheal Tube Cuff Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cylindrical tube group

The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.

Group Type ACTIVE_COMPARATOR

cylindrical endotracheal tube

Intervention Type DEVICE

endotracheal tube is intubated

tapergaurd tube group

The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.

Group Type EXPERIMENTAL

TaperGuard endotracheal tube

Intervention Type DEVICE

TaperGuard endotracheal tube is intubated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TaperGuard endotracheal tube

TaperGuard endotracheal tube is intubated

Intervention Type DEVICE

cylindrical endotracheal tube

endotracheal tube is intubated

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient who were underwent nasal intubation

Exclusion Criteria

* history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 35 kg/m2
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Younghoon Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Younghoon Jeon, Mr

Role: PRINCIPAL_INVESTIGATOR

kyungook national university hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-11-043-001

Identifier Type: -

Identifier Source: org_study_id