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Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

24 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • General Hospital Vienna
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Martin Dworschak, MD, MBA
        • Sub-investigatore:
          • Edda M. Tschernko, MD, MBA
        • Sub-investigatore:
          • Keso Skhirtladze-Dworschak, MD
        • Sub-investigatore:
          • Florentina Zingher, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Risk group
Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.
Procedura: 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%.
Procedura: Non-ventilated lung.
The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lung aeration score of both lungs.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiologic assessment of Kerley B lines as indicators of lung edema.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Length of ICU and hospital stay.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical University of Vienna

Investigatori

  • Investigatore principale: Martin Dworschak, MD, MBA, Medical University of Vienna

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 luglio 2029

Date di iscrizione allo studio

Primo inviato

4 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • EK Nr: 1250/2021

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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