Clinical trial NCT06581588: Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive sleep apnea
THRIVE
apnea time
nasopharyngeal
nasopharyngeal airway
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: duration from apnea to eighteen (18) minutes
Secondary outcomes:
measure: Arterial partial pressure of oxygen (PaO2)
timeFrame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
measure: Arterial carbon dioxide pressure (PaCO2)
timeFrame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
measure: Concentration of arterial blood lactate
timeFrame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
measure: Arterial blood pH
timeFrame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
measure: mininmum SPO2
timeFrame: from apnea start to 1minute after intubation
measure: desaturation duration(SPO2 100-99%,-98%,-95%)
timeFrame: from apnea start to 1minute after intubation
measure: Transcutaneous CO2 (tc CO2 increase rate
timeFrame: duration from apnea start to 18 minutes
measure: End-tidal carbon dioxide (ETCO2) increase rate
timeFrame: duration from apnea start to 18 minutes
measure: highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)
timeFrame: duration from apnea start to 20 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Guyan Wang
role: STUDY_DIRECTOR
References: