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Perioperative Prophylactic Positive Pressure Ventilation Reduces Postoperative Pulmonary Complications.

ConditionPostoperative Pulmonary Complications (PPCs)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJun Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Ventilation

    Other intervention

    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 ventilation

    Other intervention

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: Conventional Ventilation GroupOther 1 intervention
Group B: POP GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 1 week after surgery

Secondary outcomes

1

ICU admission rate

Time frame
Up to 1 week after surgery
2

Length of hospital stay

Time frame
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.

Time frame
Up to 1 week after surgery
4

Neutrophil extracellular traps

Time frame
Perioperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jun Zhang

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

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