Skip to main content
OpenTrials
Completed

NCT Number: NCT07211074

Optimal PEEP Level for Minimizing the Risk of Postoperative Atelectasis: A Retrospective Cohort Study Based on Lung Ultrasound Monitoring

Background: After surgery with general anesthesia, it is common for parts of the lungs to collapse, a condition called atelectasis. This can lead to low blood oxygen levels and other lung complications. Doctors use a setting on the breathing machine called PEEP (Positive End-Expiratory Pressure) to help keep the lungs open, but the best level to use is still debated.

Purpose of the Study: The goal of this research is to find a PEEP level that minimizes the risk of lung collapse and low oxygen levels after surgery. The investigators will use lung ultrasound, a safe and non-invasive imaging method, to check the health of the lungs at the patient's bedside.

The investigators will not assign treatments; they will observe the outcomes based on the PEEP level chosen by the patient's anesthesiologist during routine care. A simplified ultrasound scan will be used to score the amount of lung collapse before and after surgery. The main outcomes will be the frequency of lung collapse and the frequency of low oxygen levels (defined as SpO₂ of 90% or less).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pirogov National Medical and Surgical Cente

Moscow, 105203, Russia

About this study

Background and Rationale Postoperative pulmonary complications (PPCs) are a significant cause of morbidity and mortality, associated with a nearly 20% increase in lethality and prolonged hospital stays. The most common PPC is atelectasis, which can trigger more severe complications and develops in up to 90% of patients following the induction of general anesthesia. While computed tomography (CT) is the gold standard for diagnosing atelectasis, lung ultrasound (LUS) has emerged as a rapid, reliable, and validated bedside tool that is superior to standard chest radiography, with a high sensitivity (87.7%) and specificity (92.1%) compared to CT.

A key strategy for preventing atelectasis is the application of positive end-expiratory pressure (PEEP). While ventilation with zero PEEP is considered harmful, the optimal level remains controversial. Large randomized trials (e.g., PROVHILO, PROBESE) have not shown a benefit for universally high PEEP strategies (e.g., 12 cm H₂O) and have noted an increased risk of hemodynamic instability. This contrasts with other studies suggesting benefits from moderate or individualized PEEP levels. This study designed to address this gap by analyzing data to identify a PEEP threshold associated with minimal atelectasis and desaturation, using a simplified LUS monitoring protocol.

Study Objectives The primary objective of this study is to evaluate the effectiveness of a simplified LUS protocol for monitoring postoperative atelectasis and to determine a PEEP level associated with the minimum frequency and severity of atelectasis.

Specific study tasks include:

  • To assess the frequency and severity of postoperative atelectasis in patients with different airway management strategies and PEEP levels.
  • To determine an optimal PEEP threshold for minimizing the risk of atelectasis and desaturation using ROC analysis.
  • To compare the rates of atelectasis and desaturation (SpO₂ ≤90%) between patient subgroups.
  • To conduct a multifactorial analysis of risk factors for developing postoperative atelectasis and desaturation.
  • To evaluate the prognostic value of the LUS score for predicting the risk of postoperative desaturation.

Study Design and Methodology This is a single-center, retrospective cohort study conducted at the National Medical and Surgical Center n.a. N.I. Pirogov. The level of PEEP not assigned by the protocol but determined by the attending anesthesiologist as part of routine clinical practice.

A simplified 2-zone LUS protocol will be used, focusing on the posterior-basal lung regions most susceptible to collapse. Lung aeration will be quantified using a 4-point scoring system (0-3), with 0 indicating normal aeration and 3 indicating major consolidation. Scans will be performed by one of three competent investigators before anesthesia and within the first hours after surgery, once the patient is fully awake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing surgical intervention under general anesthesia with mechanical ventilation.
  • Airway protection managed with either an endotracheal tube or a laryngeal mask.
  • A normal baseline ultrasound of the posterior-basal lung regions, corresponding to a score of 0 on the lung ultrasound scale.

Exclusion criteria

  • Patients undergoing cardiac or thoracic surgery.
  • Presence of a perioperatively identified pneumothorax.
  • Inability to obtain adequate ultrasound visualization of the target lung zones.
  • Presence of hydrothorax.
  • Confirmed perioperative pulmonary aspiration.
  • Presence of any pathological findings on the initial baseline ultrasound of the posterior-basal lung regions.
  • Requirement for massive blood transfusion during the operation.
  • Patients undergoing surgery on the diaphragm.
  • Prolonged residual sedation lasting more than 2 hours post-operation

Treatment and study plan

Primary outcomes

  1. Frequency of Postoperative Atelectasis

    Time frame: The ultrasound measurement is performed within the first few hours after the completion of the surgical procedure

    The measure assesses the presence of postoperative atelectasis, defined as a lung ultrasound (LUS) score greater than 0. The assessment is conducted using a simplified 2-zone LUS protocol, with aeration evaluated on a 4-point scale (from 0 for normal aeration to 3 for major consolidation). The outcome is the percentage of patients who develop any degree of atelectasis (LUS score > 0) following surgery

Secondary outcomes

  1. Frequency of Postoperative Desaturation

    Time frame: Within the first few hours after completion of surgery

    The percentage of patients who experience an episode of clinically significant postoperative desaturation. This is defined as a peripheral oxygen saturation (SpO₂) of 90% or less. The measurement is recorded after the patient is fully awake and breathing spontaneously

  2. Severity of Postoperative Atelectasis Measured by Lung Ultrasound Score

    Time frame: The final LUS score is measured within the first few hours after completion of surgery

    The overall severity of postoperative atelectasis, measured by the total score from the lung ultrasound (LUS) assessment. The score is a quantitative value from 0 to 6 (up to 3 points for each of the two lung zones). This outcome is analyzed as a continuous variable, comparing the median scores between groups.

Sponsors and collaborators

Lead sponsor

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Other

Registry information

Official study title

Optimal Positive End-Expiratory Pressure (PEEP) Level for Minimizing the Risk of Postoperative Atelectasis According to Lung Ultrasound Monitoring: A Retrospective Cohort Study

Acronym: ULTRASVENT-1

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.