Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Obstructive sleep apnea, THRIVE, apnea time, nasopharyngeal, nasopharyngeal airway
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.
Interventions
DEVICETHRIVE
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen
DEVICETHRIVE combine nasopharyngeal airway
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| desaturation duration(SPO2 100-99%,-98%,-95%) | from apnea start to 1minute after intubation | desaturation duration(SPO2 100-99%,-98%,-95%) |
| 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 |
| highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five) | duration from apnea start to 20 minutes | mmHg |
| Concentration of arterial blood lactate | at the time apnea start, five/ten minutes after apnea and at the end of apnea | mmol/L |
Countries
China
Outcome results
None listed