MedDataX Logo

High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery

NCT ID: NCT05559502

Last Updated: 2023-12-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-06-30

Brief Summary

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

Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

Detailed Description

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

Laryngeal microsurgery is mainly performed by a conventional method of general anesthesia with endotracheal intubation (ET), which may have difficulty accessing the lesion behind the larynx, and may be limited in securing space for surgical manipulation. To compensate for these shortcomings, a method of maintaining general anesthesia without using an endotracheal tube has been introduced, and high-flow nasal oxygen(HFNO) and transnasal humidified rapid insufflation ventilatory exchange(THRIVE) enable tubeless anesthesia due to apnea oxygenation and apnea ventilation effect during laryngeal microsurgery. Coughing and straining can be accompanied by emergence after general anesthesia. Forceful vocal cord adduction especially after upper respiratory surgery such as laryngeal microsurgery can cause damage and bleeding of surgical tissue, delaying wound healing. If a small amount of remifentanil is continuously injected during emergence after total intravenous anesthesia(TIVA), airway complications such as coughing can be reduced during emergence without delay in recovery time, and hemodynamic stability can be promoted. In this study, the effect of endotracheal intubation and high-flow nasal oxygen on the emergence cough and postoperative sore throat is compared when total intravenous anesthesia(TIVA) using propofol and remifentanil is performed in patients undergoing laryngeal microsurgery. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

Conditions

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

Cough

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

High flow nasal oxygenation Laryngeal microsurgery emergence cough

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

DOUBLE

Participants Outcome Assessors

Study Groups

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

HFNO group

Patients will receive HFNO therapy during laryngomicrosurgery.

Group Type EXPERIMENTAL

HFNO group

Intervention Type DEVICE

HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

ET group

Endotracheal intubation was performed for general anesthesia

Group Type ACTIVE_COMPARATOR

ET group

Intervention Type DEVICE

Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Interventions

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

HFNO group

HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

Intervention Type DEVICE

ET group

Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Optiflow Portex, Smiths Medical International Ltd., South East England, United Kingdom

Eligibility Criteria

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

Inclusion Criteria

* Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia for laryngeal microsurgery

Exclusion Criteria

* Patients with major cardiovascular, pulmonary, and cerebrovascular disease
* Laser laryngeal surgery
* Morbid obesity (BMI\>35 kg/m2)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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

Jong Yeop Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

JongYeop Kim, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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

Ajou University Hospital

Suwon, Gyeongki-do, South Korea

Site Status RECRUITING

Countries

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

South Korea

Central Contacts

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

TaeKwang Kim, M.D.

Role: CONTACT

Phone: 82-031-219-5589

Email: [email protected]

JongYeop Kim, M.D.,Ph.D.

Role: CONTACT

Phone: 82-031-219-5574

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jong Yeop Kim, M.D., Ph.D.

Role: primary

Tae Kwang Kim, M.D

Role: backup

Other Identifiers

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

AJOUIRB-IV-2022-457

Identifier Type: -

Identifier Source: org_study_id