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Postoperative Pulmonary Complications (PPCs)ULTRASVENT-1NCT07211074

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

An observational study of Postoperative Pulmonary Complications (PPCs) and Postoperative Atelectasis, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
450 participants
Where
1 siteRussia
Study dates
22 Sep 2025to 31 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of 450 adult patients who underwent surgical procedures under general anesthesia with mechanical ventilation. Data will be collected from patients treated at the Department of Anesthesiology and Resuscitation of the National Medical and Surgical Center n.a. N.I. Pirogov. The cohort will be formed using a time-stratified randomization method to ensure a representative sample over the study period. All included patients will have a normal lung ultrasound before their procedure. The population will be divided based on the method of airway protection: * patients managed with an endotracheal tube (ETT). * patients managed with a laryngeal mask (LM).

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • Requirement for massive blood transfusion during the operation.
  • Patients undergoing surgery on the diaphragm.
  • Prolonged residual sedation lasting more than 2 hours post-operation

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Pirogov National Medical and Surgical Cente

    Moscow, 105203

Other trials in Russia

About this study

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

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).

Read the detailed description

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.

Keywords
Postoperative Atelectasis, Lung Ultrasound, Postoperative Desaturation, Postoperative Pulmonary Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07211074
Study groupRoleWhat they receive
ETT with PEEP ≤7 cm H₂OThis cohort consists of patients who underwent surgery with general anesthesia managed with an endotracheal tube (ETT) and a positive end-expiratory pressure (PEEP) of 7 cm H₂O or less. This group will include 250 patients in the final analysis
ETT with PEEP ≥8 cm H₂OThis cohort consists of patients who underwent surgery with general anesthesia managed with an endotracheal tube (ETT) and a positive end-expiratory pressure (PEEP) of 8 cm H₂O or greater. This group will include 119 patients in the final analysis
Laryngeal MaskThis cohort consists of patients who underwent surgery with general anesthesia managed with a laryngeal mask (LM) for airway protection. This group will include 81 patients in the final analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Postoperative Atelectasis

    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

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

Secondary outcomes (2)
  1. Frequency of Postoperative Desaturation

    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

    Measured: Within the first few hours after completion of surgery

  2. Severity of Postoperative Atelectasis Measured by Lung Ultrasound Score

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start22 Sep 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211074
Sponsor's protocol ID
NMSC-03-25
Acronym
ULTRASVENT-1
Status last verified
Feb 2026
First submitted
29 Sep 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505.

    PubMed 31157366
  • Mazzinari G, Zampieri FG, Ball L, Campos NS, Bluth T, Hemmes SNT, Ferrando C, Librero J, Soro M, Pelosi P, Gama de Abreu M, Schultz MJ, Serpa Neto A; for REPEAT on behalf of the PROVHILO, iPROVE, and PROBESE investigators and the PROVE Network investigators. High Positive End-expiratory Pressure (PEEP) with Recruitment Maneuvers versus Low PEEP during General Anesthesia for Surgery: A Bayesian Individual Patient Data Meta-analysis of Three Randomized Clinical Trials. Anesthesiology. 2025 Jan 1;142(1):72-97. doi: 10.1097/ALN.0000000000005170.

    PubMed 39042027
  • Yoon HK, Kim BR, Yoon S, Jeong YH, Ku JH, Kim WH. The Effect of Ventilation with Individualized Positive End-Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial. J Clin Med. 2021 Feb 19;10(4):850. doi: 10.3390/jcm10040850.

    PubMed 33669526
  • Cho S, Oh HW, Choi MH, Lee HJ, Woo JH. Effects of Intraoperative Ventilation Strategy on Perioperative Atelectasis Assessed by Lung Ultrasonography in Patients Undergoing Open Abdominal Surgery: a Prospective Randomized Controlled Study. J Korean Med Sci. 2020 Oct 12;35(39):e327. doi: 10.3346/jkms.2020.35.e327.

    PubMed 33045769
  • Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.

    PubMed 31587835
  • Ma J, Sun M, Song F, Wang A, Tian X, Wu Y, Wang L, Zhao Q, Liu B, Wang S, Qiu Y, Hou H, Deng L. Effect of ultrasound-guided individualized positive end-expiratory pressure on the severity of postoperative atelectasis in elderly patients: a randomized controlled study. Sci Rep. 2024 Nov 15;14(1):28128. doi: 10.1038/s41598-024-79105-8.

    PubMed 39548165
  • Liao B, Liao W, Yin S, Liu S, Wu X. Effect of ultrasound-guided lung recruitment to reduce pulmonary atelectasis after non-cardiac surgery under general anesthesia: a systematic review and meta-analysis of randomized controlled trials. Perioper Med (Lond). 2024 Mar 27;13(1):23. doi: 10.1186/s13741-024-00379-7.

    PubMed 38539248
  • Wu XZ, Xia HM, Zhang P, Li L, Hu QH, Guo SP, Li TY. Effects of ultrasound-guided alveolar recruitment manoeuvres compared with sustained inflation or no recruitment manoeuvres on atelectasis in laparoscopic gynaecological surgery as assessed by ultrasonography: a randomized clinical trial. BMC Anesthesiol. 2022 Aug 16;22(1):261. doi: 10.1186/s12871-022-01798-z.

    PubMed 35974310

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pulmonary Complications (PPCs) and Postoperative Atelectasis, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Postoperative Atelectasis (time frame: The ultrasound measurement is performed within the first few hours after the completion of the surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211074, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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