Postoperative Pulmonary Complications (PPCs)NCT07461285
Perioperative Prophylactic Positive Pressure Ventilation Reduces Postoperative Pulmonary Complications.
A study testing Conventional Ventilation and Perioperative positive pressure ventilation in people with Postoperative Pulmonary Complications (PPCs), run by Jun Zhang.
Trial summary
The incidence of postoperative pulmonary complications (PPCs) ranges from 5% to 33%. PPCs significantly prolong hospital stay, increase the economic burden, and are associated with postoperative mortality at 30 days and 1 year. The occurrence of PPCs is associated with multiple perioperative factors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Conventional Ventilation and Perioperative positive pressure ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed the informed consent form and are willing to comply with the study protocol;
- Age ≥ 18 years and ≤ 90 years;
- ASA physical status classification I to III;
- Scheduled for major elective abdominal surgery;
- Undergoing general anesthesia with endotracheal intubation;
- ARISCAT (Assessement of Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45;
- Anticipated surgery duration ≥ 2 hours.
Who cannot join
- Untreated ischemic heart disease; severe cardiovascular or cerebrovascular disease;
- Severe asthma, pulmonary bullae/bullous lung disease, pneumothorax, bronchopleural fistula, etc.;
- Severe underlying hepatic or renal disease;
- Age < 18 years or > 90 years;
- Refusal to participate in the clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Li Yang contact
About this study
The incidence of postoperative pulmonary complications (PPCs) ranges from 5% to 33%. PPCs significantly prolong hospital stay, increase the economic burden, and are associated with postoperative mortality at 30 days and 1 year. The occurrence of PPCs is associated with multiple perioperative factors. A multimodal approach may provide better prevention against PPCs. We hypothesize that perioperative prophylactic positive pressure ventilation can reduce the incidence of PPCs in patients undergoing high-risk abdominal surgery.
Read the detailed description
Globally, over 313 million surgical procedures are performed annually. The incidence of postoperative pulmonary complications (PPCs) ranges from 5% to 33%. PPCs include respiratory tract infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia, representing the second most common postoperative complication, second only to surgical site infection. PPCs significantly prolong hospital stay, increase economic burden, and are associated with 30-day and 1-year postoperative mortality.
The occurrence of PPCs is associated with multiple perioperative factors. General anesthesia induction can alter the distribution of gas within the lungs, shifting ventilation toward the ventral and left regions, resulting in decreased dorsal ventilation and varying degrees of atelectasis. This leads to ventilation inhomogeneity and ventilation-perfusion mismatch, impairing systemic oxygenation. Studies have shown that during mechanical ventilation, mechanical stress increases in atelectatic areas, potentially causing tissue hypoxia, while adjacent areas may experience overdistension and hyperoxia. Hyperoxia and overdistension promote the release of pulmonary pro-inflammatory factors, reactive oxygen species, and increased leukocyte infiltration. Research indicates that local tissue hypoxia and altered mechanical stress due to atelectasis can induce lung injury. An experimental study reported ultrastructural evidence of microvascular endothelial disruption in atelectatic lung tissue, suggesting that such damage may increase pulmonary vascular permeability and protein leakage. Furthermore, the systemic inflammatory response triggered by the nociceptive stimuli of major thoracic or abdominal surgery, combined with airway hyperreactivity, can collectively disrupt the alveolar epithelial barrier and impair mucociliary clearance. After extubation at the end of surgery, the risk of atelectasis and hypoxemia persists due to residual anesthetic effects, pain-induced suppression of the cough reflex, among other factors. These elements, combined with patient-related factors (e.g., advanced age, smoking, pre-existing lung disease), collectively contribute to the development of PPCs.
Lung-protective ventilation strategies, including low tidal volume, application of PEEP, and intermittent recruitment maneuvers, are now widely used clinically to prevent PPCs. Some scholars posit that the primary principle of lung-protective ventilation is the prophylactic perioperative use of positive pressure ventilation (P.O.P-ventilation), aimed at minimizing the reduction in lung volume throughout the perioperative period. Evidence suggests that prophylactic positive pressure ventilation applied before anesthesia induction, during surgery, and after tracheal extubation can reduce the incidence of adverse postoperative respiratory events. Although lung-protective ventilation is increasingly adopted, critical gaps in evidence remain. How to best implement a multimodal, perioperative prophylactic positive pressure ventilation strategy to reduce PPCs requires further investigation. Therefore, in a preliminary study, we divided 120 patients scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation into three groups, applying 0, 5, or 10 cm H₂O of positive end-expiratory pressure (PEEP) during anesthesia induction, respectively, and observed the incidence of post-induction atelectasis. Our results showed that 10 cm H₂O of PEEP significantly reduced the occurrence of atelectasis following induction. However, this preliminary study did not follow up on the incidence of postoperative PPCs.
Building upon our preliminary findings, and to further evaluate the safety and efficacy of perioperative prophylactic positive pressure ventilation in reducing PPCs, we propose the following strategies for our new clinical study: (1) Increase the sample size and enroll patients undergoing abdominal surgery at intermediate-to-high risk for PPCs (Assessement of Respiratory Risk in Surgical Patients in Catalonia score, ARISCAT score ≥ 45); (2) Implement a multimodal strategy for prophylactic positive airway pressure. This includes using 10 cm H₂O PEEP during anesthesia induction, applying electrical impedance tomography (EIT)-guided individualized PEEP during surgery, and utilizing high-flow nasal cannula (HFNC) oxygen therapy after tracheal extubation to maintain positive end-expiratory pressure. (3) Follow up and assess PPCs occurring within 7 days postoperatively during the hospital stay. Through these strategies, we aim to further establish the protective role of a perioperative prophylactic positive pressure ventilation strategy on postoperative lung outcomes, thereby providing an enhanced empirical foundation for optimizing the clinical prevention of PPCs.
- Being tested
- Conventional Ventilation, Perioperative positive pressure ventilation
- Keywords
- Postoperative pulmonary complications, positive pressure ventilation, abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional VentilationOther
No PEEP is applied during anesthesia induction; conventional PEEP of 5 cmH₂O is used during surgery; and after tracheal extubation, conventional face mask oxygen therapy (at an oxygen flow rate of 5 L/min) is administered.
Perioperative positive pressure ventilationOther
A PEEP of 10 cmH₂O is applied during general anesthesia induction; EIT-guided individualized PEEP is utilized during surgery; and following tracheal extubation, high-flow nasal cannula (HFNC) oxygen therapy (with an FiO₂ of 40%) is administered to maintain positive end-expiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ventilation Group | Other | In this group, no PEEP is applied during anesthesia induction; conventional PEEP of 5 cmH₂O is used intraoperatively; and conventional face-mask oxygen therapy (at an oxygen flow rate of 5 L/min) is administered after tracheal extubation. Receives: Other: Conventional Ventilation |
| POP Group | Experimental | Perioperative Prophylactic Positive Airway Pressure Group. In this group, a PEEP of 10 cmH₂O is applied during general anesthesia induction; EIT-guided individualized PEEP is utilized during surgery; and following tracheal extubation, high-flow nasal cannula (HFNC) oxygen therapy (with an FiO₂ of 40%) is administered to maintain positive end-expiratory pressure. Receives: Other: Perioperative positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PPCs
Postoperative pulmonary complications (PPCs) are a group of adverse respiratory events occurring after surgery, representing a major cause of morbidity and mortality. Common PPCs include atelectasis, pneumonia, respiratory failure, pleural effusion, and bronchospasm. They are associated with prolonged hospital stay, increased healthcare costs, and higher short- and long-term mortality. Risk factors include patient age, pre-existing lung disease, smoking, and the type and duration of surgery/anesthesia. Preventive strategies, such as lung-protective ventilation, early mobilization, and incentive spirometry, are crucial in high-risk patients. Monitoring and timely management of PPCs are essential for improving surgical outcomes.
Measured: Up to 1 week after surgery
Secondary outcomes (4)
ICU admission rate
Measured: Up to 1 week after surgery
Length of hospital stay
Measured: Whole hospital stay
Postoperative pain score
The postoperative Visual Analog Scale (VAS) pain score is a simple, widely used tool for quantifying a patient's subjective pain intensity. It typically consists of a 10-cm horizontal line anchored by the descriptors "no pain" (0) on the left and "worst pain imaginable" (10) on the right. The patient marks the line at a point corresponding to their pain level, and the score is determined by measuring the distance in centimeters from the left anchor.
In the postoperative context, scores are often categorized for clinical interpretation: 0-3 cm indicates mild pain, 4-6 cm moderate pain, and 7-10 cm severe pain. It is a validated and sensitive instrument for tracking pain trends over time and assessing the effectiveness of analgesic interventions, forming a cornerstone of multimodal pain management protocols.
Measured: Up to 1 week after surgery
Neutrophil extracellular traps
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, Study chair, Fudan University Shanghai Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461285
- Sponsor's protocol ID
- 2510-Exp297
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Prophylactic Positive Pressure Ventilation Reduces Postoperative Pulmonary Complications.
- ClinicalTrials.gov ID
- NCT07461285
- Acronym / sponsor ID
- 2510-Exp297
- Keywords
- Postoperative pulmonary complications, positive pressure ventilation, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Mar 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 postoperative pulmonary complications (PPCs) ranges from 5% to 33%. PPCs significantly prolong hospital stay, increase the economic burden, and are associated with postoperative mortality at 30 days and 1 year. The occurrence of PPCs is associated with multiple perioperative factors. A multimodal approach may provide better prevention against PPCs. We hypothesize that perioperative prophylactic positive pressure ventilation can reduce the incidence of PPCs in patients undergoing high-risk abdominal surgery.
Detailed description
Globally, over 313 million surgical procedures are performed annually. The incidence of postoperative pulmonary complications (PPCs) ranges from 5% to 33%. PPCs include respiratory tract infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia, representing the second most common postoperative complication, second only to surgical site infection. PPCs significantly prolong hospital stay, increase economic burden, and are associated with 30-day and 1-year postoperative mortality.
The occurrence of PPCs is associated with multiple perioperative factors. General anesthesia induction can alter the distribution of gas within the lungs, shifting ventilation toward the ventral and left regions, resulting in decreased dorsal ventilation and varying degrees of atelectasis. This leads to ventilation inhomogeneity and ventilation-perfusion mismatch, impairing systemic oxygenation. Studies have shown that during mechanical ventilation, mechanical stress increases in atelectatic areas, potentially causing tissue hypoxia, while adjacent areas may experience overdistension and hyperoxia. Hyperoxia and overdistension promote the release of pulmonary pro-inflammatory factors, reactive oxygen species, and increased leukocyte infiltration. Research indicates that local tissue hypoxia and altered mechanical stress due to atelectasis can induce lung injury. An experimental study reported ultrastructural evidence of microvascular endothelial disruption in atelectatic lung tissue, suggesting that such damage may increase pulmonary vascular permeability and protein leakage. Furthermore, the systemic inflammatory response triggered by the nociceptive stimuli of major thoracic or abdominal surgery, combined with airway hyperreactivity, can collectively disrupt the alveolar epithelial barrier and impair mucociliary clearance. After extubation at the end of surgery, the risk of atelectasis and hypoxemia persists due to residual anesthetic effects, pain-induced suppression of the cough reflex, among other factors. These elements, combined with patient-related factors (e.g., advanced age, smoking, pre-existing lung disease), collectively contribute to the development of PPCs.
Lung-protective ventilation strategies, including low tidal volume, application of PEEP, and intermittent recruitment maneuvers, are now widely used clinically to prevent PPCs. Some scholars posit that the primary principle of lung-protective ventilation is the prophylactic perioperative use of positive pressure ventilation (P.O.P-ventilation), aimed at minimizing the reduction in lung volume throughout the perioperative period. Evidence suggests that prophylactic positive pressure ventilation applied before anesthesia induction, during surgery, and after tracheal extubation can reduce the incidence of adverse postoperative respiratory events. Although lung-protective ventilation is increasingly adopted, critical gaps in evidence remain. How to best implement a multimodal, perioperative prophylactic positive pressure ventilation strategy to reduce PPCs requires further investigation. Therefore, in a preliminary study, we divided 120 patients scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation into three groups, applying 0, 5, or 10 cm H₂O of positive end-expiratory pressure (PEEP) during anesthesia induction, respectively, and observed the incidence of post-induction atelectasis. Our results showed that 10 cm H₂O of PEEP significantly reduced the occurrence of atelectasis following induction. However, this preliminary study did not follow up on the incidence of postoperative PPCs.
Building upon our preliminary findings, and to further evaluate the safety and efficacy of perioperative prophylactic positive pressure ventilation in reducing PPCs, we propose the following strategies for our new clinical study: (1) Increase the sample size and enroll patients undergoing abdominal surgery at intermediate-to-high risk for PPCs (Assessement of Respiratory Risk in Surgical Patients in Catalonia score, ARISCAT score ≥ 45); (2) Implement a multimodal strategy for prophylactic positive airway pressure. This includes using 10 cm H₂O PEEP during anesthesia induction, applying electrical impedance tomography (EIT)-guided individualized PEEP during surgery, and utilizing high-flow nasal cannula (HFNC) oxygen therapy after tracheal extubation to maintain positive end-expiratory pressure. (3) Follow up and assess PPCs occurring within 7 days postoperatively during the hospital stay. Through these strategies, we aim to further establish the protective role of a perioperative prophylactic positive pressure ventilation strategy on postoperative lung outcomes, thereby providing an enhanced empirical foundation for optimizing the clinical prevention of PPCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Ventilation Group | Other | Other: Conventional VentilationIn this group, no PEEP is applied during anesthesia induction; conventional PEEP of 5 cmH₂O is used intraoperatively; and conventional face-mask oxygen therapy (at an oxygen flow rate of 5 L/min) is administered after tracheal extubation. |
| POP Group | Experimental | Other: Perioperative positive pressure ventilationPerioperative Prophylactic Positive Airway Pressure Group. In this group, a PEEP of 10 cmH₂O is applied during general anesthesia induction; EIT-guided individualized PEEP is utilized during surgery; and following tracheal extubation, high-flow nasal cannula (HFNC) oxygen therapy (with an FiO₂ of 40%) is administered to maintain positive end-expiratory pressure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have signed the informed consent form and are willing to comply with the study protocol;
- Age ≥ 18 years and ≤ 90 years;
- ASA physical status classification I to III;
- Scheduled for major elective abdominal surgery;
- Undergoing general anesthesia with endotracheal intubation;
Key exclusion criteria (5 listed)
- Untreated ischemic heart disease; severe cardiovascular or cerebrovascular disease;
- Severe asthma, pulmonary bullae/bullous lung disease, pneumothorax, bronchopleural fistula, etc.;
- Severe underlying hepatic or renal disease;
- Age < 18 years or > 90 years;
- Refusal to participate in the clinical study.
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 VentilationNo PEEP is applied during anesthesia induction; conventional PEEP of 5 cmH₂O is used during surgery; and after tracheal extubation, conventional face mask oxygen therapy (at an oxygen flow rate of 5 L/min) is administered. | Other | Conventional Ventilation Group |
| Perioperative positive pressure ventilationA PEEP of 10 cmH₂O is applied during general anesthesia induction; EIT-guided individualized PEEP is utilized during surgery; and following tracheal extubation, high-flow nasal cannula (HFNC) oxygen therapy (with an FiO₂ of 40%) is administered to maintain positive end-expiratory pressure. | Other | POP Group |
Primary outcome
Incidence of PPCs
Time frame: Up to 1 week after surgery
Postoperative pulmonary complications (PPCs) are a group of adverse respiratory events occurring after surgery, representing a major cause of morbidity and mortality. Common PPCs include atelectasis, pneumonia, respiratory failure, pleural effusion, and bronchospasm. They are associated with prolonged hospital stay, increased healthcare costs, and higher short- and long-term mortality. Risk factors include patient age, pre-existing lung disease, smoking, and the type and duration of surgery/anesthesia. Preventive strategies, such as lung-protective ventilation, early mobilization, and incentive spirometry, are crucial in high-risk patients. Monitoring and timely management of PPCs are essential for improving surgical outcomes.
4 secondary outcomes
ICU admission rate
Time frame: Up to 1 week after surgery
Length of hospital stay
Time frame: Whole hospital stay
Postoperative pain score
Time frame: Up to 1 week after surgery
Neutrophil extracellular traps
Time frame: Perioperative
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 10 Mar 2026.
- Individual participant dataSharing planned: No. The data sets are available from the corresponding author on reasonable request.
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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.
Li Yang contact
Jun Zhang study chair
Fudan University Shanghai Cancer Centre
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Ventilation and Perioperative positive pressure ventilation in people with Postoperative Pulmonary Complications (PPCs), run by Jun Zhang.
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 7 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 10 Mar 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 Jun Zhang Fudan University, Professor (13817153025, snapzhang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PPCs (time frame: Up to 1 week 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 10 Mar 2026.