MedDataX Logo

E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck

NCT ID: NCT02949856

Last Updated: 2016-10-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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

This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.

Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.

Detailed Description

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

Conditions

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

Thyroidectomy

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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

Tapered

Mallinckrodt, COVIDIEN

Group Type EXPERIMENTAL

Mallinckrodt, COVIDIEN

Intervention Type DEVICE

Cylindrical

Endotracheal tube, Unomedical

Group Type ACTIVE_COMPARATOR

Endotracheal tube, Unomedica

Intervention Type DEVICE

Interventions

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

Mallinckrodt, COVIDIEN

Intervention Type DEVICE

Endotracheal tube, Unomedica

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

Exclusion Criteria

* difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

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

Yong-Cheol Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yong-Cheol Lee, MD, PhD

Role: CONTACT

Phone: 82-53-250-7193

Email: [email protected]

Other Identifiers

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

2016-05-032-001

Identifier Type: -

Identifier Source: org_study_id