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Completed

NCT Number: NCT06581588

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THRIVE

Device

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen

THRIVE combine nasopharyngeal airway

Device

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Arterial partial pressure of oxygen (PaO2)

    Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea

    Unit: mmHg

  2. Arterial carbon dioxide pressure (PaCO2)

    Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea

    Unit: mmHg

  3. Concentration of arterial blood lactate

    Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea

    mmol/L

  4. Arterial blood pH

    Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea

    Unitless

  5. mininmum SPO2

    Time frame: from apnea start to 1minute after intubation

    mininmum SPO2

  6. desaturation duration(SPO2 100-99%,-98%,-95%)

    Time frame: from apnea start to 1minute after intubation

    desaturation duration(SPO2 100-99%,-98%,-95%)

  7. Transcutaneous CO2 (tc CO2 increase rate

    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

  8. End-tidal carbon dioxide (ETCO2) increase rate

    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

  9. highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)

    Time frame: duration from apnea start to 20 minutes

    mmHg

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study 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

Acronym: THRIVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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