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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 SpOâ‚‚ of 90% or less).
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 Hâ‚‚O) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETT with PEEP ≤7 cm H₂O | This 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 H₂O | This 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 Mask | This 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The ultrasound measurement is performed within the first few hours after the completion of the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (SpOâ‚‚) of 90% or less. The measurement is recorded after the patient is fully awake and breathing spontaneously | Within the first few hours after completion of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Teplykh, MD | Pirogov National Medical and Surgical Center | Study Director |
| Ivan Shcheparev, MD, PhD | Pirogov National Medical and Surgical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov National Medical and Surgical Cente | Moscow | 105203 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31157366 | Background | 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. | |
| 39042027 |
| Label | URL |
|---|---|
| Official website of the Pirogov National Medical and Surgical Center | View source |
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2 months after completion of the study
upon the request
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| 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. | The final LUS score is measured within the first few hours after completion of surgery |
| Background |
| 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. |
| 33669526 | Background | 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. |
| 33045769 | Background | 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. |
| 31587835 | Background | 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. |
| 39548165 | Background | 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. |
| 38539248 | Background | 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. |
| 35974310 | Background | 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. |