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Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

24. mai 2026 oppdatert av: Dr. Martin Dworschak, Medical University of Vienna

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications

This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Østerrike
    • State of Vienna
      • Vienna, State of Vienna, Østerrike, 1090
        • General hospital Vienna
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Martin Dworschak, MD, MBA
        • Underetterforsker:
          • Edda M. Tschernko, MD, MBA
        • Underetterforsker:
          • Keso Skhirtladze-Dworschak, MD
        • Underetterforsker:
          • Florentina Zingher, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients at increased risk for postoperative pulmonary complications
  • Major elective cardiac surgery
  • Prolonged duration of cardiopulmonary bypass
  • Patients older than 65 years of age
  • Informed consent

Exclusion Criteria:

  • Emergency
  • Urgent procedures
  • Patients with implanted pacemakers
  • Patients with internal cardioverter/defibrillators
  • Decompensated cardiac disease
  • Pulmonary disease
  • Recent pneumonia
  • Need for temporary perioperative mechanical support
  • Patients not willing to participate
  • Treatment with inhaled nitric oxide

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Risk group
Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.
Fremgangsmåte: Ventilated lung
This lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%.
Fremgangsmåte: Non-ventilated lung.
The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lung aeration score of both lungs.
Tidsramme: Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.
The aeration score of each lung is the sum of the aeration scores determined in each of six lung quadrants in each lung, which can range from 0 (normal ventilation) to 3 (atelectasis/consolidation).
Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Radiologic assessment of Kerley B lines as indicators of lung edema.
Tidsramme: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Number of Kerley B lines in both lungs determined by chest x-ray where stage 1 (no Kerley B lines) reflects best outcome, stage 2 (Kerley B lines become visible) indicates interstitial edema, and stage 3 (increased number of Kerley B lines also in non-dependent areas and partially obscured in dependent parts of the lung) are a sign of alveolar edema.
Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Presence of pleural effusion in chest x-ray.
Tidsramme: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Severity assessment will be semi-quantitative with 0 = no effusion, 1 = small effusion (with blunting of the basal lung segments and the costophrenic angle), 2 = moderate effusion (fluid extents to the mid-hemithorax creating a "meniscus sign"), and 3 = massive effusion (the whole lung appears opaque with displacement of the heart to the contralateral side if located unilaterally).
Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Determination of the Global Inhomogeneity (GI) index in both lungs separately by thoracic Electrical Impedance Tomography (EIT).
Tidsramme: On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
Global inhomogeneity is calculated as the sum of the absolute differences between the median value of tidal variation and every single pixel value, divided by the sum of all impedance values, to normalize the calculated values. A GI index closer to 0 represents highly homogeneous (even) ventilation. Higher values (i.e., > 0.5) indicate that some parts of the lung are over-distended while others are poorly aerated or collapsed (atelectasis).
On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
Worst oxygenation (Horowitz) index measured per day during routine blood gas checks.
Tidsramme: Assessed on the day of surgery and on day 1 and 2 after surgery.
The Horowitz index (HI) is calculated by diving arterial oxygen partial pressure determined in the blood gas by the fraction of inspired oxygen. It will be assessed after each blood gas check and the lowest HI during one day will be entered for further statistical analysis. The degree of impaired lung function will be determined as follows: HI > 300 mmHg (healthy lung function), HI between 201-300 mmHg (mild lung injury), HI between 101-200 mmHg (moderately severely impaired lung function), and HI < 100 mmHg (severe lung injury, ARDS).
Assessed on the day of surgery and on day 1 and 2 after surgery.
Static lung compliance determined in each lung separately.
Tidsramme: On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
Static lung compliance of the ventilated and the non-ventilated lung will be determined twice for each patient. Static compliance in healthy adults ranges between 60 and 100 mL/cm H₂O. Values below 50 mL/cm H₂O would be considered abnormally low.
On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
Amount of released immune modulators.
Tidsramme: Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.
Serum levels for HSP70, MMP-8, MMP-9, TIMP-1, and Lipocalin-2 will be determined in patients' blood samples, with normal values ranging from 0.2-3 ng/mL for HSP70, 0.3-1.2 ng/mL for MMP-8, 14-100 ng/mL for MMP-9, 80-150 ng/mL for TIMP-1, and 20-130 ng/mL for Lipocalin-2, respectively.
Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of ICU and hospital stay.
Tidsramme: These variables will be censored at study completion, on average 30 days.
The duration from transfer to the intensive care unit until discharge to a step-down unit and the duration of hospitalization of the patient will be determined in days.
These variables will be censored at study completion, on average 30 days.
In-hospital mortality.
Tidsramme: In-hospital mortality will be censored at study completion, on average 30 days.
It will be recorded if the patient has been discharged from the hospital alive.
In-hospital mortality will be censored at study completion, on average 30 days.
Duration on respiratory support via endotracheal tube.
Tidsramme: The time until extubation will be censored at study completion, on average 30 days.
The hours between arrival of the intubated patient on the intensive care unit until extubation will be determined.
The time until extubation will be censored at study completion, on average 30 days.
Postoperative complications.
Tidsramme: All complications will be censored at study completion, on average 30 days.
Any complication that poses a risk for the patient occurring during the hospital stay and having been documented in the patient's file will be retrieved by carefully reviewing the files and recorded.
All complications will be censored at study completion, on average 30 days.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medical University of Vienna

Etterforskere

  • Hovedetterforsker: Martin Dworschak, MD, MBA, Medical University of Vienna

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. juli 2029

Datoer for studieregistrering

Først innsendt

4. april 2026

Først innsendt som oppfylte QC-kriteriene

24. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • EK Nr: 1250/2021

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The primary reason for not sharing IPD is the protection of patient privacy.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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