Pulmonary ComplicationsNCT07372378
Association of Different Tidal Volumes and Postoperative Pulmonary Complications
An observational study of Pulmonary Complications and Hypoxemia During Surgery, run by First Affiliated Hospital of Zhejiang University.
Trial summary
The incidence of lung cancer in China is increasing year by year. Currently, the treatment primarily based on video-assisted thoracoscopic surgery (VATS) is still considered the optimal approach for early-stage non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Pulmonary Complications, Hypoxemia During Surgery, Thoracic Surgery, Video Assisted
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Feb 2029
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing video-assisted lung surgery
Who may be able to join
- Age > 50 years.
- ASA physical status I-II.
- The cardiopulmonary and other vital organ functions are basically normal, and the patient is able to tolerate surgery.
- Ariscat score > 26.
- Informed consent has been obtained.
Who cannot join
- Patients who refuse to participate in the clinical trial, or have cognitive impairment or impaired ability to understand and express themselves.
- ASA physical status ≥ III.
- Patients with congestive heart failure, severe aortic stenosis, or extensive pleural adhesions.
- Patients with severe psychiatric disorders or allergy to anesthesia-related medications.
- Patients with severe organ dysfunction such as the liver or kidney dysfunction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association of Various Introperative Tidal Volumes and Postoperative Pulmonary Complications After Video-assisted Thoracic Surgery
The incidence of lung cancer in China is increasing year by year. Currently, the treatment primarily based on video-assisted thoracoscopic surgery (VATS) is still considered the optimal approach for early-stage non-small cell lung cancer. The widespread application of traditional one-lung ventilation (OLV) technology not only achieves effective lung isolation, but also facilitates exposure of the surgical field during thoracoscopic surgery, making it more convenient for surgeons to operate. However, the occurrence of hypoxemia during one-lung ventilation may pose a risk to patient safety.
One-lung ventilation can lead to increased intrapulmonary shunt, ventilation/perfusion (V/Q) mismatch, and ischemic-hypoxic lung injury. Hypoxemia is the major problem during one-lung ventilation. Postoperative pulmonary complications (PPCs) are among the major complications following thoracic and general anesthesia surgeries, including atelectasis, pneumonia, and respiratory failure, which significantly prolong hospital stay and increase mortality.
Read more
Low tidal volume lung-protective ventilation strategies have been widely implemented. Additionally, permissive hypercapnia, reducing peak airway pressure to minimize barotrauma, and decreasing FiO₂ all help reduce pulmonary complications.Recently, researchers have focused on optimizing ventilation strategies during OLV, such as using PEEP or low VT ventilation alone or in combination, or exploring different combinations of tidal volume and respiratory frequency under consistent minute ventilation (VE), aiming to balance lung protection and oxygenation, reduce complications, and improve patient outcomes.
However, to date, there is still no gold standard tidal volume ventilation strategy for reducing pulmonary complications in patients undergoing lung resection.
- Conditions
- Pulmonary Complications, Hypoxemia During Surgery, Thoracic Surgery, Video Assisted, One Lung Ventillation (OLV), Lung Cancer (Non-Small Cell)
- Keywords
- pulmonary complications, hypoxemia, video-assisted thoracic surgery, one lung ventilation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary Complications (PPCs)
Postoperative Pulmonary Complications (PPCs): Incidence of any PPC within 7 days postoperatively
Measured: 1-7 days after surgery
Secondary outcomes (2)
Incidence of hypoxemia
Incidence of hypoxemia: Occurring before the end of surgery
Measured: during surgery
Length of Hospital Stay
Length of Hospital Stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion24 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372378
- Sponsor's protocol ID
- VolumePPC
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Various Introperative Tidal Volumes and Postoperative Pulmonary Complications After Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07372378
- Acronym / sponsor ID
- VolumePPC
- Conditions
- Pulmonary Complications, Hypoxemia During Surgery, Thoracic Surgery, Video Assisted, One Lung Ventillation (OLV), Lung Cancer (Non-Small Cell)
- Keywords
- pulmonary complications, hypoxemia, video-assisted thoracic surgery, one lung ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 24 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 28 Jan 2026 (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 incidence of lung cancer in China is increasing year by year. Currently, the treatment primarily based on video-assisted thoracoscopic surgery (VATS) is still considered the optimal approach for early-stage non-small cell lung cancer. The widespread application of traditional one-lung ventilation (OLV) technology not only achieves effective lung isolation, but also facilitates exposure of the surgical field during thoracoscopic surgery, making it more convenient for surgeons to operate. However, the occurrence of hypoxemia during one-lung ventilation may pose a risk to patient safety.
One-lung ventilation can lead to increased intrapulmonary shunt, ventilation/perfusion (V/Q) mismatch, and ischemic-hypoxic lung injury. Hypoxemia is the major problem during one-lung ventilation. Postoperative pulmonary complications (PPCs) are among the major complications following thoracic and general anesthesia surgeries, including atelectasis, pneumonia, and respiratory failure, which significantly prolong hospital stay and increase mortality.
Low tidal volume lung-protective ventilation strategies have been widely implemented. Additionally, permissive hypercapnia, reducing peak airway pressure to minimize barotrauma, and decreasing FiO₂ all help reduce pulmonary complications.Recently, researchers have focused on optimizing ventilation strategies during OLV, such as using PEEP or low VT ventilation alone or in combination, or exploring different combinations of tidal volume and respiratory frequency under consistent minute ventilation (VE), aiming to balance lung protection and oxygenation, reduce complications, and improve patient outcomes.
However, to date, there is still no gold standard tidal volume ventilation strategy for reducing pulmonary complications in patients undergoing lung resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing video-assisted lung surgery
Key inclusion criteria (5 listed)
- Age > 50 years.
- ASA physical status I-II.
- The cardiopulmonary and other vital organ functions are basically normal, and the patient is able to tolerate surgery.
- Ariscat score > 26.
- Informed consent has been obtained.
Key exclusion criteria (5 listed)
- Patients who refuse to participate in the clinical trial, or have cognitive impairment or impaired ability to understand and express themselves.
- ASA physical status ≥ III.
- Patients with congestive heart failure, severe aortic stenosis, or extensive pleural adhesions.
- Patients with severe psychiatric disorders or allergy to anesthesia-related medications.
- Patients with severe organ dysfunction such as the liver or kidney dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pulmonary Complications (PPCs)
Time frame: 1-7 days after surgery
Postoperative Pulmonary Complications (PPCs): Incidence of any PPC within 7 days postoperatively
2 secondary outcomes
Incidence of hypoxemia
Time frame: during surgery
Length of Hospital Stay
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Complications and Hypoxemia During Surgery, run by First Affiliated Hospital of Zhejiang 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Ye, M.D. (8615267048716, yehui@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pulmonary Complications (PPCs) (time frame: 1-7 days after surgery). 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 28 Jan 2026.