Mechanical Power and Pulmonary Complications in CABG Surgery (MP-CABG)
6. juni 2026 opdateret af: Fusun Gozen
Association of Intraoperative Mechanical Power With Postoperative Pulmonary Complications and Prolonged Mechanical Ventilation in Coronary Artery Bypass Graft Surgery
This prospective observational study evaluates the association between intraoperative mechanical power (MP) - a composite measure of the total energy delivered to the lungs during mechanical ventilation - and postoperative pulmonary complications (PPCs) and prolonged mechanical ventilation in adult patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Intraoperative ventilatory parameters including tidal volume, respiratory rate, airway pressures, and PEEP will be recorded and used to calculate MP and driving pressure (DP).
No additional interventions will be applied beyond standard clinical care.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This single-center prospective observational study enrolls adult patients undergoing elective first-time isolated coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Mechanical power (MP) will be calculated as: MP = 0.098 × RR
× VT × [PIP - 0.5 × (Pplat - PEEP)], normalized to predicted body weight (norMP = MP/PBW). Male PBW (kg) = 50 + 0.91 × [height (cm) - 152.4]; female PBW (kg) = 45.5 + 0.91 × [height (cm) - 152.4]. Driving pressure (DP) = Pplat - PEEP.
Ventilatory parameters (VT, RR, peak pressure, plateau pressure, PEEP, FiO2, EtCO2) and arterial blood gases (PaO2/FiO2, PaCO2, lactate) will be recorded at four standardized time points: T1 (post-intubation), T2 (post- sternotomy), T3 (pre-bypass), and T4 (post-bypass). No additional interventions beyond standard clinical care will be applied.
Postoperative outcomes including atelectasis, pneumonia, pleural effusion, prolonged oxygen requirement, need for non-invasive ventilation, re-intubation, duration of mechanical ventilation, and ICU length of stay will be assessed within the first 48 hours.
Sample size: 110 patients (α=0.05, power=80%, expected PPC incidence 35% vs 65% in low vs high MP groups, 20% dropout allowance). Statistical analysis will include Mann-Whitney U or t-test, chi-square or Fisher exact test, and logistic regression. Significance: p<0.05 (two-tailed).
Undersøgelsestype
Observationel
Tilmelding (Anslået)
110
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Füsun Gözen, MD (Anesthesiology)
- Telefonnummer: +902242955000
- E-mail: fusungozen@gmail.com
Studiesteder
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-
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Bursa, Tyrkiet (Türkiye)
- Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass at a single tertiary cardiac surgery center
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective, first-time isolated CABG surgery
- Use of cardiopulmonary bypass (CPB)
- Intraoperative mechanical ventilation applied under general anesthesia with recordable ventilator data
- Provision of written informed consent
Exclusion Criteria:
- Emergency cardiac surgery
- Off-pump CABG (without CPB)
- Preoperative requirement for invasive mechanical ventilation
- Advanced chronic lung disease
- Incomplete or unreliable intraoperative ventilatory data
- Intraoperative use of advanced non-standard support (ECMO)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
CABG Patients
Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass.
Intraoperative ventilatory parameters will be recorded to calculate mechanical power and driving pressure.
|
Intraoperative ventilatory parameters (tidal volume, respiratory rate, plateau pressure, PEEP) are routinely recorded during CABG surgery.
Mechanical power and driving pressure are calculated from these parameters.
No additional intervention is applied beyond standard clinical care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pulmonary Complication
Tidsramme: Within the first 48 hours postoperatively
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Occurrence of at least one of the following within the first 48 hours postoperatively: atelectasis, pleural effusion, pneumonia, prolonged oxygen requirement, need for non-invasive ventilation (NIV), or re-intubation
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Within the first 48 hours postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prolonged Mechanical Ventilation
Tidsramme: Up to 7 days postoperatively
|
Duration of mechanical ventilation greater than 24 hours
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Up to 7 days postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
- Elefterion B, Cirenei C, Kipnis E, Cailliau E, Bruandet A, Tavernier B, Lamer A, Lebuffe G. Intraoperative Mechanical Power and Postoperative Pulmonary Complications in Noncardiothoracic Elective Surgery Patients: A 10-Year Retrospective Cohort Study. Anesthesiology. 2024 Mar 1;140(3):399-408. doi: 10.1097/ALN.0000000000004848.
- Schuijt MTU, Hol L, Nijbroek SG, Ahuja S, van Meenen D, Mazzinari G, Hemmes S, Bluth T, Ball L, Gama-de Abreu M, Pelosi P, Schultz MJ, Serpa Neto A. Associations of dynamic driving pressure and mechanical power with postoperative pulmonary complications-posthoc analysis of two randomised clinical trials in open abdominal surgery. EClinicalMedicine. 2022 Apr 16;47:101397. doi: 10.1016/j.eclinm.2022.101397. eCollection 2022 May.
- Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Zhu Y, Peng W, Zhen S, Jiang X. Mechanical power normalized to predicted body weight is associated with mortality in critically ill patients: a cohort study. BMC Anesthesiol. 2021 Nov 10;21(1):278. doi: 10.1186/s12871-021-01497-1.
- Li T, Zhailauova A, Wachruschew I, Kuanyshbek A, Tulegenov S, Bukirova P, Zhakupbekov B, Nikitin I, Ayaganov D, Kapyshev T, Samalavicius R, Melnikov AL, Aslanidis T. Impact of Ventilation Discontinuation During Cardiopulmonary Bypass: A Prospective Observational Study. J Clin Med. 2025 Nov 19;14(22):8215. doi: 10.3390/jcm14228215.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
6. juni 2026
Først opslået (Faktiske)
10. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024-TBEK 2026/01-18 (Anden identifikator: Bursa Yuksek Ihtisas Training and Research Hospital Ethics Committee)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared.
This is a single-center observational study conducted at a public hospital.
Data sharing is not planned due to institutional privacy regulations and the absence of external funding requiring data sharing.
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