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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Jun Zhang Fudan University, Professor contact

13817153025

snapzhang@aliyun.com

Li Yang contact

liyangmagic@sina.com

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 groups in NCT07461285
Study groupRoleWhat they receive
Conventional Ventilation GroupOtherIn 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 GroupExperimentalPerioperative 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.

  1. 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)
  1. ICU admission rate

    Measured: Up to 1 week after surgery

  2. Length of hospital stay

    Measured: Whole hospital stay

  3. 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

  4. 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.

  1. First posted10 Mar 2026
  2. Study start20 Mar 2026 (estimated)
  3. Primary completion20 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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)
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.

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.

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