Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Individualized PEEP and Pulmonary Complications in On-Pump CABG

1. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Mechanical Power Group
Driving pressure-guided individualized PEEP group
Sonstiges: 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.
Sonstiges: Lung Protective Ventilation
Conventional lung-protective ventilation group
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
postoperative pulmonary complications
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Inflammatory markers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Time from intubation to successfull extubation
Duration of mechanical ventilation
Time from intubation to successfull extubation
30 day mortality
Zeitfenster: postoperative 30 day mortality
30 day mortality
postoperative 30 day mortality
Hospital lenght of stay
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bursa City Hospital

Ermittler

  • Studienstuhl: eralp cevikkalp, Burs City Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

  • 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.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

15. Juni 2026

Studienabschluss (Geschätzt)

15. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Herzchirugie

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Japan

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren