Lung DisorderNCT05720845
Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
A study testing VESPA and conventional mechanical ventilation in people with Lung Disorder, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Disorder
- What is being tested?
- VESPA and conventional mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2023to 18 Mar 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
- Adult patients undergoing interventional pulmonology procedures with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
- Recent (< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy
Who cannot join
- Patients with baseline lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) in dependent areas of the lung (right/left [R/L] B6, 9, or 10 bronchial segments) as seen on most recent CT
- History of primary or secondary spontaneous pneumothorax
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. Ventilatory strategy to prevent reduce the intra-procedural development of atelectasis during interventional pulmonology procedures under general anesthesia.
- Conditions
- Lung Disorder
- Being tested
- VESPA, conventional mechanical ventilation
- Keywords
- atelectasis, general anesthesia
- Medical subject headings
- Lung Diseases, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESPAProcedure or surgery
Using Ventilatory strategy of prevent atelectasis for General Anesthesia.
conventional mechanical ventilationProcedure or surgery
Conventional mechanical ventilation for General Anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| conventional mechanical ventilation | Active comparator | Conventional mechanical ventilation for General Anesthesia Receives: Procedure: conventional mechanical ventilation |
| VESPA | Experimental | ventilatory strategy to prevent atelectasis for General Anesthesia Receives: Procedure: VESPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of new atelectasis for each segment
The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS)
Measured: During bronchoscopy, an average of 1 hour.
Secondary outcomes (3)
Ventilation-induced complications
Measured: Within 48 hours of bronchoscopy
Bronchoscopy-induced complications
Measured: Within 48 hours of bronchoscopy
Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
Measured: During bronchoscopy, an average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start8 Feb 2023 (estimated)
- Primary completion18 Jan 2025 (estimated)
- Study completion18 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720845
- Sponsor's protocol ID
- 20230111
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 9 Feb 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
- ClinicalTrials.gov ID
- NCT05720845
- Acronym / sponsor ID
- 20230111
- Conditions
- Lung Disorder
- Keywords
- atelectasis, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 8 Feb 2023 (estimated)
- Primary completion
- 18 Jan 2025 (estimated)
- Study completion
- 18 Mar 2025 (estimated)
- First posted
- 9 Feb 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.
This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. Ventilatory strategy to prevent reduce the intra-procedural development of atelectasis during interventional pulmonology procedures under general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional mechanical ventilation | Active comparator | Procedure: conventional mechanical ventilationConventional mechanical ventilation for General Anesthesia |
| VESPA | Experimental | Procedure: VESPAventilatory strategy to prevent atelectasis for General Anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing interventional pulmonology procedures with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
- Recent (< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy
Key exclusion criteria (2 listed)
- Patients with baseline lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) in dependent areas of the lung (right/left [R/L] B6, 9, or 10 bronchial segments) as seen on most recent CT
- History of primary or secondary spontaneous pneumothorax
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 |
|---|---|---|
| VESPAUsing Ventilatory strategy of prevent atelectasis for General Anesthesia. | Procedure or surgery | VESPA |
| conventional mechanical ventilationConventional mechanical ventilation for General Anesthesia. | Procedure or surgery | conventional mechanical ventilation |
Primary outcome
Presence or absence of new atelectasis for each segment
Time frame: During bronchoscopy, an average of 1 hour.
The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS)
3 secondary outcomes
Ventilation-induced complications
Time frame: Within 48 hours of bronchoscopy
Bronchoscopy-induced complications
Time frame: Within 48 hours of bronchoscopy
Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
Time frame: During bronchoscopy, an average of 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
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 study testing VESPA and conventional mechanical ventilation in people with Lung Disorder, run by Guangzhou Institute of Respiratory Disease 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 2 inclusion and 2 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 9 Feb 2023. 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?
Results are not available in the source record.
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?
Presence or absence of new atelectasis for each segment (time frame: During bronchoscopy, an average of 1 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 9 Feb 2023.