Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients (THRIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: THRIVE; Device: THRIVE combine nasopharyngeal airway

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oxygenation using THRIVE technique; oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute	Device: THRIVE; Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen
Experimental: THRIVE combined nasopharyngeal airway; 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 and nasopharyngeal airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Study Director: Guyan Wang, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): April 13, 2025
• Study Completion (Actual): April 13, 2025

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; THRIVE; nasopharyngeal; apnea time; nasopharyngeal airway
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: TREC2024-KY069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No