Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-04-13

Brief Summary

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

The purpose of the study is to compare effectiveness of different methods of achieving oxygenation in obstructive sleep apnea patients. The investigators intend to compare transnasal humidified rapid-insufflation ventilator exchange (THRIVE) combined with nasopharyngeal airway with THRIVE alone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures

NCT04171037

Obstructive Sleep Apnea

COMPLETED NA

Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea

NCT05549245

Obstructive Sleep Apnea

UNKNOWN NA

Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea

NCT05549310

Obstructive Sleep Apnea High Flow Nasal Canula Continuous Positive Airway Pressure Ventilation

UNKNOWN NA

Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea

NCT01553383

Obstructive Sleep Apnea Adverse Effects

COMPLETED NA

Randomized Cross-over TRD and CPAP for OSA

NCT02788487

Obstructive Sleep Apnea

UNKNOWN NA

Detailed Description

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

With the increasing prevalence of obesity, the prevalence of OSA is also rising, ranging from 9% to 25% in the general adult population. Patients with OSA have features of an anatomically tricky airway due to a crowded collapsible pharyngeal space, compounded by physiological problems related to lower functional residual capacity and increased oxygen consumption, leading to faster oxygen desaturation. Meanwhile, patients with OSA, compared to patients without OSA, have a 3-4 times higher risk of difficult intubation, difficult mask ventilation, or both. Apnoea time is a potentially hazardous period during induction of anesthesia and it is particularly so in patients with OSA. OSA patients undergoing general anesthesia gave rise to many concerns and challenges, and strategies to extend the apneic time were required. Identifying the most effective method of oxygenating OSA patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.

Conditions

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

Obstructive Sleep Apnea Syndrome

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

PREVENTION

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.

oxygenation using THRIVE technique

oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute

Group Type ACTIVE_COMPARATOR

THRIVE

Intervention Type DEVICE

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen

THRIVE combined nasopharyngeal airway

oxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute

Group Type EXPERIMENTAL

THRIVE combine nasopharyngeal airway

Intervention Type DEVICE

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway

Interventions

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

THRIVE

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen

Intervention Type DEVICE

THRIVE combine nasopharyngeal airway

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* patients aged between 18 and 75 years requiring general anesthesia
* American society of Anesthesiologists (ASA) physical status classification system: I - III
* diagnosed as OSA.

Exclusion Criteria

* Patients with chronic respiratory disease, uncontrolled hypertension, ischemic heart disease, congestive heart failure, increased intracranial pressure, gastroesophageal reflux disease,
* patients' arterial hemoglobin saturation \< 98% after preoxygenation,
* patients were nasal obstruction
* patients with previous or anticipated difficult facemask ventilation or intubation,
* patients with known allergy or contraindication to propofol, remifentanil, rocuronium, or midazolam.
* patients who were unable to give informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No