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Individualized PEEP and Pulmonary Complications in On-Pump CABG

1 juni 2026 uppdaterad av: eralp çevikkalp, Bursa City Hospital

Effect of Individualized PEEP Guided by Driving Pressure and Mechanical Power on Postoperative Pulmonary Complications in On-Pump CABG: A Randomized Controlled Trial

Postoperative pulmonary complications (PPCs) are an important cause of morbidity and mortality after major surgery and are frequently observed in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These complications are associated with prolonged mechanical ventilation, longer intensive care unit and hospital stays, increased healthcare costs, and higher mortality (1,2).

Intraoperative lung-protective ventilation strategies have traditionally focused on individual parameters such as low tidal volume, positive end-expiratory pressure (PEEP), plateau pressure, and driving pressure. However, the effects of these parameters on postoperative pulmonary outcomes in cardiac surgery patients remain unclear. In particular, PEEP- and driving pressure-guided approaches are controversial in terms of feasibility and safety in patients undergoing CPB, who may be hemodynamically vulnerable.

Mechanical power is a comprehensive parameter that reflects the total energy delivered to the respiratory system per unit of time by integrating ventilatory variables such as tidal volume, airway pressures, respiratory rate, and flow. Therefore, mechanical power may provide a more comprehensive assessment of the mechanical load applied to the lungs compared with individual ventilatory parameters. Previous studies have reported that higher mechanical power values may be associated with lung injury, postoperative pulmonary complications, and mortality (3).

The aim of this study is to evaluate the effect of monitoring mechanical power during perioperative mechanical ventilation on postoperative pulmonary complications in patients undergoing cardiac surgery with cardiopulmonary bypass. The study hypothesis is that a mechanical power-based ventilation approach may reduce the incidence of PPCs compared with strategies based on conventional ventilation parameters.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Postoperative pulmonary complications (PPCs) are an important cause of morbidity and mortality after major surgery and are frequently observed in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These complications are associated with prolonged mechanical ventilation, longer intensive care unit and hospital stays, increased healthcare costs, and higher mortality (1,2).

Intraoperative lung-protective ventilation strategies have traditionally focused on individual parameters such as low tidal volume, positive end-expiratory pressure (PEEP), plateau pressure, and driving pressure. However, the effects of these parameters on postoperative pulmonary outcomes in cardiac surgery patients remain unclear. In particular, PEEP- and driving pressure-guided approaches are controversial in terms of feasibility and safety in patients undergoing CPB, who may be hemodynamically vulnerable.

Mechanical power is a comprehensive parameter that reflects the total energy delivered to the respiratory system per unit of time by integrating ventilatory variables such as tidal volume, airway pressures, respiratory rate, and flow. Therefore, mechanical power may provide a more comprehensive assessment of the mechanical load applied to the lungs compared with individual ventilatory parameters. Previous studies have reported that higher mechanical power values may be associated with lung injury, postoperative pulmonary complications, and mortality (3).

The aim of this study is to evaluate the effect of monitoring mechanical power during perioperative mechanical ventilation on postoperative pulmonary complications in patients undergoing cardiac surgery with cardiopulmonary bypass. The study hypothesis is that a mechanical power-based ventilation approach may reduce the incidence of PPCs compared with strategies based on conventional ventilation parameters.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Patients with ASA physical status II-III who are scheduled to undergo elective open-heart surgery via on-pump median sternotomy will be included in the study.

Patients scheduled for emergency surgery, those planned to undergo off-pump cardiac surgery, patients with a history of myocardial infarction within the last 3 months, patients with advanced COPD, patients with an ARISCAT score of 44 or higher, patients with a BMI of 35 kg/m² or higher, patients with NYHA class IV status, patients receiving preoperative immunotherapy, and patients with severe hepatic or renal failure will be excluded from the study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Mechanical Power Group
Driving pressure-guided individualized PEEP group
Övrig: Driving pressure-based personalized PEEP strategy

After hemodynamic stability is achieved, the ventilator will be switched to volume-controlled mode with 6 ml/kg tidal volume , and a recruitment maneuver will be performed by gradually increasing PEEP to 20 cmH₂O. Subsequently, during the decremental PEEP trial, PEEP will be reduced by 2 cmH₂O every 20 seconds down to 6 cmH₂O, and ΔP (Pplat-PEEP) will be calculated at each step.

The PEEP level associated with the lowest ΔP on the ΔP-PEEP curve will be identified, a second recruitment maneuver will be performed, and PEEP will then be fixed at this level. Before sternotomy, the minimum PEEP value that provides the lowest driving pressure will be determined, and this value will be maintained throughout the perioperative period, except during cardiopulmonary bypass.
Övrig: Lung Protective Ventilation
Conventional lung-protective ventilation group
Övrig: Conventional lung protective mechanical ventilation strategy
In volume-controlled mechanical ventilation, tidal volume will be set at 6 mL/kg and PEEP will be fixed at 5 cmH₂O. Ventilation will be maintained with these settings throughout the perioperative period, except during cardiopulmonary bypass. Mechanical power values will also be calculated and recorded during all these periods.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative pulmonary complications
Tidsram: postoperative day 1,3,7
Postoperative pulmonary complications, including atelectasis, pneumonia, respiratory failure, pleural effusion, pneumothorax, and bronchospasm, will be assessed according to the EPCO(European Perioperative Clinical Outcome) criteria.
postoperative day 1,3,7

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Inflammatory markers
Tidsram: Postoperative 1., 24, 48,72 hour and day 7
Postoperative biochemical markers, including CRP, neutrophil count, lymphocyte count, procalcitonin, white blood cell count, IL-6, and TNF-α, will be evaluated.
Postoperative 1., 24, 48,72 hour and day 7
İCU lenght of stay
Tidsram: From postoperative ICU admission to ICU discharge, assessed up to 30 days
Duration of İCU lenght of stay
From postoperative ICU admission to ICU discharge, assessed up to 30 days
Duration of mechanical ventilation
Tidsram: Time from intubation to successfull extubation
Duration of mechanical ventilation
Time from intubation to successfull extubation
30 day mortality
Tidsram: postoperative 30 day mortality
30 day mortality
postoperative 30 day mortality
Hospital lenght of stay
Tidsram: From hospital admission to hospital discharge, assessed up to 30 days
Hospital lenght of stay
From hospital admission to hospital discharge, assessed up to 30 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bursa City Hospital

Utredare

  • Studiestol: eralp cevikkalp, Burs City Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 1. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data Neto, Ary Serpa et al. The Lancet Respiratory Medicine, Volume 4, Issue 4, 272 - 280 2. Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. 3. Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. PMID: 27620287. 4. Li XF, Jiang RJ, Mao WJ, Yu H, Xin J, Yu H. The effect of driving pressure-guided versus conventional mechanical ventilation strategy on pulmonary complications following on-pump cardiac surgery: A randomized clinical trial. J Clin Anesth. 2023 Oct;89:111150. doi: 10.1016/j.jclinane.2023.111150. Epub 2023 Jun 10. PMID: 37307653.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 maj 2026

Primärt slutförande (Beräknad)

15 juni 2026

Avslutad studie (Beräknad)

15 juli 2026

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 25.03.2026 2026-6/7
  • 26-AKD-57 (Annan identifierare: Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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