NCT06581588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2025

Completed
Last Updated

April 17, 2025

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 18, 2023

Last Update Submit

April 15, 2025

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive sleep apneaTHRIVEapnea timenasopharyngealnasopharyngeal airway

Outcome Measures

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.

    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 Outcomes (9)

  • Arterial partial pressure of oxygen (PaO2)

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

  • Arterial carbon dioxide pressure (PaCO2)

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

  • Concentration of arterial blood lactate

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

  • Arterial blood pH

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

  • mininmum SPO2

    from apnea start to 1minute after intubation

  • +4 more secondary outcomes

Study Arms (2)

oxygenation using THRIVE technique

ACTIVE COMPARATOR

oxygenation delivered via nasal high flow humidified oxygen (Optiflow) . 70 litres/minute

Device: THRIVE

THRIVE combined nasopharyngeal airway

EXPERIMENTAL

oxygenation delivered via nasopharyngeal airway and THRIVE technique. 70 litres/minute

Device: THRIVE combine nasopharyngeal airway

Interventions

THRIVEDEVICE

Device: Optiflow and THRIVE technique Nasal high flow humidified oxygen

oxygenation using THRIVE technique
THRIVE combine nasopharyngeal airwayDEVICE

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

THRIVE combined nasopharyngeal airway

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 18 and 75 years requiring general anesthesia
  • American society of Anesthesiologists (ASA) physical status classification system: I - III
  • diagnosed as OSA.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

  • 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.

    PMID: 40217470DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Guyan Wang

    Beijing Tongren Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 3, 2024

Study Start

September 1, 2024

Primary Completion

April 13, 2025

Study Completion

April 13, 2025

Last Updated

April 17, 2025

Record last verified: 2024-08

Locations

CN(1)