Perioperative Prophylactic Positive Pressure Ventilation Reduces Postoperative Pulmonary Complications.

NCT07461285 | Not Yet Recruiting DMC

• 1 other identifier: 2510-Exp297
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Postoperative Pulmonary Complications (PPCs)

Keywords

Postoperative pulmonary complications; positive pressure ventilation; abdominal surgery

Outcome Measures

Primary Outcomes (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.

  Up to 1 week after surgery

Secondary Outcomes (4)

• ICU admission rate

  Up to 1 week after surgery

• Length of hospital stay

  Whole hospital stay

• Postoperative pain score

  Up to 1 week after surgery

• Neutrophil extracellular traps

  Perioperative

Study Arms (2)

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.

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.

Other: Perioperative positive pressure ventilation

Interventions

Conventional Ventilation OTHER

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.

Conventional Ventilation Group

Perioperative positive pressure ventilation OTHER

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.

POP Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun Zhang: lead

Study Officials

• Jun Zhang

  Fudan University Shanghai Cancer Centre

  STUDY CHAIR

Central Study Contacts

Jun Zhang Fudan University, Professor

CONTACT

13817153025; snapzhang@aliyun.com

Li Yang

CONTACT

liyangmagic@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: March 10, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share