Obstructive Sleep Apnea SyndromeTHRIVENCT06581588
Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients
A study testing THRIVE and THRIVE combine nasopharyngeal airway in people with Obstructive Sleep Apnea Syndrome, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- THRIVE and THRIVE combine nasopharyngeal airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 13 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 18 and 75 years requiring general anesthesia
- American society of Anesthesiologists (ASA) physical status classification system: I - III
- diagnosed as OSA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- THRIVE, THRIVE combine nasopharyngeal airway
- Keywords
- Obstructive sleep apnea, THRIVE, apnea time, nasopharyngeal, nasopharyngeal airway
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEDevice
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen
THRIVE combine nasopharyngeal airwayDevice
Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway
| Study group | Role | What they receive |
|---|---|---|
| oxygenation using THRIVE technique | Active comparator | oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute Receives: Device: THRIVE |
| THRIVE combined nasopharyngeal airway | Experimental | oxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute Receives: Device: THRIVE combine nasopharyngeal airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration from apnea to eighteen (18) minutes
Secondary outcomes (9)
Arterial partial pressure of oxygen (PaO2)
Unit: mmHg
Measured: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial carbon dioxide pressure (PaCO2)
Unit: mmHg
Measured: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Concentration of arterial blood lactate
mmol/L
Measured: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial blood pH
Unitless
Measured: at the time apnea start, five/ten minutes after apnea and at the end of apnea
mininmum SPO2
mininmum SPO2
Measured: from apnea start to 1minute after intubation
desaturation duration(SPO2 100-99%,-98%,-95%)
desaturation duration(SPO2 100-99%,-98%,-95%)
Measured: 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
Measured: 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
Measured: duration from apnea start to 18 minutes
highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)
mmHg
Measured: duration from apnea start to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completion13 Apr 2025
- Study completion13 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581588
- Sponsor's protocol ID
- TREC2024-KY069
- Acronym
- THRIVE
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lei G, Wu L, Xi C, Yang S, Yang Q, Su S, Wang G. Apneic oxygenation with Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) in obstructive sleep apnea patients: study protocol of a randomized controlled trial. BMC Anesthesiol. 2025 Apr 11;25(1):177. doi: 10.1186/s12871-025-03055-5.
PubMed 40217470
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06581588
- Acronym / sponsor ID
- THRIVE / TREC2024-KY069
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive sleep apnea, THRIVE, apnea time, nasopharyngeal, nasopharyngeal airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 13 Apr 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygenation using THRIVE technique | Active comparator | Device: THRIVEoxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute |
| THRIVE combined nasopharyngeal airway | Experimental | Device: THRIVE combine nasopharyngeal airwayoxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 18 and 75 years requiring general anesthesia
- American society of Anesthesiologists (ASA) physical status classification system: I - III
- diagnosed as OSA.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVEDevice: Optiflow and THRIVE technique Nasal high flow humidified oxygen | Device | oxygenation using THRIVE technique |
| THRIVE combine nasopharyngeal airwayDevice: Optiflow and THRIVE technique Nasal high flow humidified oxygen and nasopharyngeal airway | Device | THRIVE combined nasopharyngeal airway |
Primary outcome
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.
9 secondary outcomes
Arterial partial pressure of oxygen (PaO2)
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial carbon dioxide pressure (PaCO2)
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Concentration of arterial blood lactate
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
Arterial blood pH
Time frame: at the time apnea start, five/ten minutes after apnea and at the end of apnea
mininmum SPO2
Time frame: from apnea start to 1minute after intubation
desaturation duration(SPO2 100-99%,-98%,-95%)
Time frame: from apnea start to 1minute after intubation
Transcutaneous CO2 (tc CO2 increase rate
Time frame: duration from apnea start to 18 minutes
End-tidal carbon dioxide (ETCO2) increase rate
Time frame: duration from apnea start to 18 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 40217470Lei G, Wu L, Xi C, Yang S, Yang Q, Su S, Wang G. Apneic oxygenation with Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) in obstructive sleep apnea patients: study protocol of a randomized controlled trial. BMC Anesthesiol. 2025 Apr 11;25(1):177. doi: 10.1186/s12871-025-03055-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guyan Wang study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE and THRIVE combine nasopharyngeal airway in people with Obstructive Sleep Apnea Syndrome, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: duration from apnea to eighteen (18) minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.