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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome

• Registration Number: NCT06581588
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-18
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-30
• Study Start: 2024-09-01
• Study First Posted: 2024-09-03
• Primary Completion: 2025-04-13
• Study Completion: 2025-04-13
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 95%. Comparing oxygenation with THRIVE combined with nasopharyngeal or THRIVE technique.	duration from apnea to eighteen (18) minutes	oxygenation is delivered either by THRIVE combined with nasopharyngeal or the THRIVE technique alone. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 95% is recorded. When this occurs the trial is stopped and the patient is intubated.If 18 minutes is reached before SpO2 = 95% then the trial is stopped.

Secondary Outcome Measures

Name	Time	Method
Arterial partial pressure of oxygen (PaO2)	at the time apnea start, five/ten minutes after apnea and at the end of apnea	Unit: mmHg
Arterial carbon dioxide pressure (PaCO2)	at the time apnea start, five/ten minutes after apnea and at the end of apnea	Unit: mmHg
Concentration of arterial blood lactate	at the time apnea start, five/ten minutes after apnea and at the end of apnea	mmol/L
Arterial blood pH	at the time apnea start, five/ten minutes after apnea and at the end of apnea	Unitless
mininmum SPO2	from apnea start to 1minute after intubation	mininmum SPO2
desaturation duration(SPO2 100-99%,-98%,-95%)	from apnea start to 1minute after intubation	desaturation duration(SPO2 100-99%,-98%,-95%)
Transcutaneous CO2 (tc CO2 increase rate	duration from apnea start to 18 minutes	mmHg= (the tcCO2 value at the end of apnea duration minus the tcCO2 value at the beginning of the apnea duration)/apnea duration
End-tidal carbon dioxide (ETCO2) increase rate	duration from apnea start to 18 minutes	mmHgmmHg= (the ETCO2 value at the end of apnea duration minus the ETCO2 value at the beginning of the apnea duration)/apnea duration
highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)	duration from apnea start to 20 minutes	mmHg

Trial Locations

Locations (1)

Beijing tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China