Clinical trial · Interventional
COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing fiberoptic bronchoscopy under propofol sedation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchiectasis | — | UNRESOLVED | — |
| Endotracheal Tumour | — | UNRESOLVED | — |
| Pulmonary Infection | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- the COMBO Endoscopy Oropharyngeal Airway Group
- description
- In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
- interventionNames
- Device: the COMBO Endoscopy Oropharyngeal Airway
Primary outcomes (1)
- measure
- The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
- timeFrame
- Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
Secondary outcomes (2)
- measure
- The incidence of sub-clinical respiratory depression（90% ≤ SpO2 < 95%）
- timeFrame
- Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18≤ Age ≤70.·Patients undergoing fiberoptic bronchoscopy. * Patients have signed the informed consent form. * The ASA classification ranges from I to II. * The estimated duration of the procedure does not exceed 45 minutes. Exclusion Criteria: * Patients with contraindications to oropharyngeal airway ventilation, such as coagulation disorders, predisposition to oral/nasal bleeding, mucosal damage, or anatomical obstructions hindering oropharyngeal airway placement. * Patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (COPD) or those currently suffering from other acute/chronic pulmonary conditions requiring long-term or intermittent oxygen therapy. * Patients with preoperative SpO₂ \< 95% while breathing air. * Patients with BMI \< 18.5 or BMI \> 30. * Patients with upper respiratory tract infections (oral, nasal, or pharyngeal). * Patients at risk of aspiration. * Patients with fever (core temperature \> 37.5°C). * Patients with severe cardiac insufficiency (\< 4 METs). * Patients with severe renal insufficiency requiring preoperative dialysis. * Patients with a confirmed diagnosis of hepatic insufficiency. * Patients with increased intracranial pressure. * Patients with hypersensitivity to sedatives like propofol or medical equipment such as adhesive tape. * Patients with a history of drug abuse and/or alcoholism within the two years preceding the commencement of the screening period (defined as drinking more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu). * Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis. * Patients currently participating in other clinical trials. * Patients deemed ineligible for participation in this clinical trial by the researchers.
References
Publications (0)
Data not yet available