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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxygenation using THRIVE technique | Active Comparator | oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute |
|
| THRIVE combined nasopharyngeal airway | Experimental | oxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE | Device | Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | duration from apnea to eighteen (18) minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial partial pressure of oxygen (PaO2) | Unit: mmHg | at the time apnea start, five/ten minutes after apnea and at the end of apnea |
| Arterial carbon dioxide pressure (PaCO2) | Unit: mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guyan Wang | Beijing Tongren Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40217470 | Derived | Lei G, Wu L, Xi C, Yang S, Yang Q, Su S, Wang G. Apneic oxygenation with Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) in obstructive sleep apnea patients: study protocol of a randomized controlled trial. BMC Anesthesiol. 2025 Apr 11;25(1):177. doi: 10.1186/s12871-025-03055-5. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| THRIVE combine nasopharyngeal airway | Device | Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway |
|
| at the time apnea start, five/ten minutes after apnea and at the end of apnea |
| Concentration of arterial blood lactate | mmol/L | at the time apnea start, five/ten minutes after apnea and at the end of apnea |
| Arterial blood pH | Unitless | at the time apnea start, five/ten minutes after apnea and at the end of apnea |
| mininmum SPO2 | mininmum SPO2 | from apnea start to 1minute after intubation |
| desaturation duration(SPO2 100-99%,-98%,-95%) | desaturation duration(SPO2 100-99%,-98%,-95%) | from apnea start to 1minute after intubation |
| Transcutaneous CO2 (tc CO2 increase rate | mmHg= (the tcCO2 value at the end of apnea duration minus the tcCO2 value at the beginning of the apnea duration)/apnea duration | duration from apnea start to 18 minutes |
| End-tidal carbon dioxide (ETCO2) increase rate | mmHgmmHg= (the ETCO2 value at the end of apnea duration minus the ETCO2 value at the beginning of the apnea duration)/apnea duration | duration from apnea start to 18 minutes |
| highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five) | mmHg | duration from apnea start to 20 minutes |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |