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

Capital Medical University

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: THRIVE; Device: THRIVE combine nasopharyngeal airway

Study type: Interventional

Funder types: Other

Identifiers

NCT06581588

TREC2024-KY069

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

oxygenation using THRIVE technique

Active Comparator group

Description:

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

Treatment:

Device: THRIVE

THRIVE combined nasopharyngeal airway

Experimental group

Description:

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

Treatment:

Device: THRIVE combine nasopharyngeal airway