BronchoscopyNCT05956301
Effects of Different Ventilatory Strategy During Bronchoscopy
A study testing Conventional Oxygen Therapy, High-flow nasal oxygen and Supraglottic jet oxygenation and ventilation in people with Bronchoscopy, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Conventional Oxygen Therapy, High-flow nasal oxygen and Supraglottic jet oxygenation and ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2023to 30 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need for bronchial endoscopy
Who cannot join
- life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks need for invasive or non invasive ventilation presence of pneumothorax or pulmonary enphisema or bullae recent (within 1 week) thoracic surgery presence of chest burns presence of tracheostomy pregnancy nasal or nasopharyngeal diseases dementia lack of consent or its withdrawal
Trial locations and contacts
No sites are listed yet.
About this study
The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures.
Our study aim was to evaluate the efficacy and complications of High-flow nasal oxygen (HFNO) via Supraglottic jet oxygenation and ventilation (SJOV)during flexible bronchoscopy.
- Conditions
- Bronchoscopy
- Being tested
- Conventional Oxygen Therapy, High-flow nasal oxygen, Supraglottic jet oxygenation and ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Oxygen TherapyDevice
Conventional Oxygen Therapy will be administered through Nasal catheter
High-flow nasal oxygenDevice
High Flow Nasal Cannula will be administered
Supraglottic jet oxygenation and ventilationDevice
Nasal jet tube will be administered
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Conventional Oxygen Therapy Receives: Device: Conventional Oxygen Therapy |
| Group II | Experimental | High-flow nasal oxygen Receives: Device: High-flow nasal oxygen |
| Group III | Experimental | Supraglottic jet oxygenation and ventilation Receives: Device: Supraglottic jet oxygenation and ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the intraoperative oxygenation.
The study will monitor the SpO2， heart rate(HR) and mean arterial pressure (MAP) during the procedure.
Measured: During bronchoscopy, an average of 0.5 hour.
Secondary outcomes (2)
Arterial blood gases
Arterial blood gas analysis will be monitored at end of of procedure.
Measured: At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.
Assess the regional ventilation distribution by Electrical impedance tomography .
Measurements will be done after bronchoscope insertion and at the end of the procedure.
Measured: During bronchoscopy, an average of 0.5 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liya Lu, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956301
- Sponsor's protocol ID
- 20230618
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Ventilatory Strategy During Bronchoscopy
- ClinicalTrials.gov ID
- NCT05956301
- Acronym / sponsor ID
- 20230618
- Conditions
- Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Jul 2023 (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 execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures.
Our study aim was to evaluate the efficacy and complications of High-flow nasal oxygen (HFNO) via Supraglottic jet oxygenation and ventilation (SJOV)during flexible bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Conventional Oxygen TherapyConventional Oxygen Therapy |
| Group II | Experimental | Device: High-flow nasal oxygenHigh-flow nasal oxygen |
| Group III | Experimental | Device: Supraglottic jet oxygenation and ventilationSupraglottic jet oxygenation and ventilation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need for bronchial endoscopy
Key exclusion criteria (1 listed)
- life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks need for invasive or non invasive ventilation presence of pneumothorax or pulmonary enphisema or bullae recent (within 1 week) thoracic surgery presence of chest burns presence of tracheostomy pregnancy nasal or nasopharyngeal diseases dementia lack of consent or its withdrawal
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 |
|---|---|---|
| Conventional Oxygen TherapyConventional Oxygen Therapy will be administered through Nasal catheter | Device | Group I |
| High-flow nasal oxygenHigh Flow Nasal Cannula will be administered | Device | Group II |
| Supraglottic jet oxygenation and ventilationNasal jet tube will be administered | Device | Group III |
Primary outcome
Compare the intraoperative oxygenation.
Time frame: During bronchoscopy, an average of 0.5 hour.
The study will monitor the SpO2， heart rate(HR) and mean arterial pressure (MAP) during the procedure.
2 secondary outcomes
Arterial blood gases
Time frame: At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.
Assess the regional ventilation distribution by Electrical impedance tomography .
Time frame: During bronchoscopy, an average of 0.5 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Oxygen Therapy, High-flow nasal oxygen and Supraglottic jet oxygenation and ventilation in people with Bronchoscopy, run by The First Affiliated Hospital of Guangzhou Medical University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liya Lu (+86-020-83062885, 2412183636@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the intraoperative oxygenation. (time frame: During bronchoscopy, an average of 0.5 hour.). 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 21 Jul 2023.