Beijing tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
NCT Number: NCT06581588
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway
Time frame: 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.
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Unit: mmHg
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Unit: mmHg
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
mmol/L
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Unitless
Time frame: from apnea start to 1minute after intubation
mininmum SPO2
Time frame: from apnea start to 1minute after intubation
desaturation duration(SPO2 100-99%,-98%,-95%)
Time frame: 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
Time frame: 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
Time frame: duration from apnea start to 20 minutes
mmHg
Beijing Tongren Hospital
Other
Apnoeic Oxygenation in Obstructive Sleep Apnea: a Randomised Controlled Trial Comparing Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) Combined With Nasopharyngeal Airway and THRIVE Alone
Acronym: THRIVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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