An interventional study of THRIVE and THRIVE combine nasopharyngeal airway in Obstructive Sleep Apnea Syndrome, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Prevention
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute
Device: THRIVE
oxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute
Device: THRIVE combine nasopharyngeal airway
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway
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.
Time frame: duration from apnea to eighteen (18) minutes
Arterial partial pressure of oxygen (PaO2)
Unit: mmHg
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial carbon dioxide pressure (PaCO2)
Unit: mmHg
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Concentration of arterial blood lactate
mmol/L
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial blood pH
Unitless
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
mininmum SPO2
mininmum SPO2
Time frame: from apnea start to 1minute after intubation
desaturation duration(SPO2 100-99%,-98%,-95%)
desaturation duration(SPO2 100-99%,-98%,-95%)
Time frame: 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
Time frame: 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
Time frame: duration from apnea start to 18 minutes
highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)
mmHg
Time frame: duration from apnea start to 20 minutes
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Beijing Tongren Hospital