Pulmonary InfectionPhase 2NCT07063290
COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
A Phase 2 study testing the COMBO Endoscopy Oropharyngeal Airway in people with Pulmonary Infection and Pulmonary Nodule, run by Zhejiang University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Infection, Pulmonary Nodule, Endotracheal Tumour
- What is being tested?
- the COMBO Endoscopy Oropharyngeal Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 18 Sep 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310000
About this study
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.
- Being tested
- the COMBO Endoscopy Oropharyngeal Airway
- Keywords
- the COMBO Endoscopy Oropharyngeal Airway, fiberoptic bronchoscopy, hypoxia
- Medical subject headings
- Bronchiectasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the COMBO Endoscopy Oropharyngeal AirwayDevice
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Other | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. Receives: Device: the COMBO Endoscopy Oropharyngeal Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression（90% ≤ SpO2 < 95%）
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start23 Jun 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The COMBO Endoscopy Oropharyngeal Airway integrates a bite block, capnography monitoring, oxygenation support, and an innovative oropharyngeal airway design. The COMBO device is a novel airway management device with integrated capnography monitoring and dual oxygenation support. It was developed to overcome persistent challenges in maintaining airway patency and oxygenation during bronchoscopy under sedation.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063290
- Sponsor's protocol ID
- ZJU2025B0779
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
- ClinicalTrials.gov ID
- NCT07063290
- Acronym / sponsor ID
- ZJU2025B0779
- Keywords
- the COMBO Endoscopy Oropharyngeal Airway, fiberoptic bronchoscopy, hypoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 14 Jul 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The COMBO Endoscopy Oropharyngeal Airway integrates a bite block, capnography monitoring, oxygenation support, and an innovative oropharyngeal airway design. The COMBO device is a novel airway management device with integrated capnography monitoring and dual oxygenation support. It was developed to overcome persistent challenges in maintaining airway patency and oxygenation during bronchoscopy under sedation.
| Arm | Type | Receives |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Other | Device: the COMBO Endoscopy Oropharyngeal AirwayIn this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
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 |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal AirwayUsing the COMBO Endoscopy Oropharyngeal Airway for oxygenation. | Device | the COMBO Endoscopy Oropharyngeal Airway Group |
Primary outcome
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
2 secondary outcomes
The incidence of sub-clinical respiratory depression（90% ≤ SpO2 < 95%）
Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）
Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing the COMBO Endoscopy Oropharyngeal Airway in people with Pulmonary Infection and Pulmonary Nodule, run by Zhejiang University 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 4 inclusion and 16 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 24 Feb 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s） (time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.