Pirogov National Medical and Surgical Cente
Moscow, 105203, Russia
NCT Number: NCT07211074
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Moscow, 105203, Russia
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Other
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
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.
NCT07186920
Lung Diseases, Lung Ultrasonography Score
Pátrai, Greece
View Trial DetailsNCT04677309
Lung Cancer, Lung Diseases
Valencia, Spain
View Trial DetailsNCT07000760
Postoperative Pulmonary Complications (PPCs)
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06609616
Postoperative Pulmonary Complications (PPCs)
Bethesda, Maryland, United States
View Trial Details