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Optimal PEEP for Postoperative Oxygenation and Lung Aeration (ULTRASVENT-2)

NCT07613177 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-29

No results posted yet for this study

Summary

The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2/FiO2 (S/F ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation.

Patients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.

Conditions

  • Postoperative Complications
  • Respiratory Insufficiency
  • Pulmonary Atelectasis
  • Positive-End Expiratory Pressure
  • Hypoxemia

Interventions

PROCEDURE

Intraoperative Positive End-Expiratory Pressure (PEEP) Regulation

Application of fixed PEEP levels calculated according to surgical aggressiveness and the presence of pneumoperitoneum. Standard PEEP arm utilizes PEEP values of 5 cm H2O. Higher PEEP arm utilizes protective PEEP values of 8 or 12 cm H2O. The assigned PEEP strategy is initiated immediately following endotracheal intubation and maintained continuously until extubation.

Sponsors & Collaborators

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    lead OTHER_GOV

Principal Investigators

  • Ivan Shcheparev, MD, PhD · Moscow Multi-disciplinary Clinical Center "Kommunarka"

  • Denis Protsenko, MD, PhD, Professor · Moscow Multi-disciplinary Clinical Center "Kommunarka"

  • Efim Shifman, MD, PhD, Professor · Moscow Multi-disciplinary Clinical Center "Kommunarka"

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-01
Completion
2026-12-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613177 on ClinicalTrials.gov