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Acute Respiratory Distress SyndromeNCT02155387

Extravascular Lung Water and Pulmonary Vascular Permeability After Minimally Invasive Cardiac Surgery

An observational study of Acute Respiratory Distress Syndrome, run by University Hospital Freiburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The use of cardiopulmonary bypass (CPB) combined with one lung ventilation (OLV) allows to perform minimally invasive cardiac surgery (MICS) through small incisions. MICS is described to be associated with similar outcomes compared with conventional surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Respiratory Distress Syndrome
How many people
30 participants
Where
1 siteGermany
Study dates
Apr 2014to Apr 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients between 18 and 75 years who need one of following surgeries: coronary artery bypass graft surgery with CPB, resection of pulmonary metastases with OLV, or minimally invasive mitral valve surgery with CPB and OLV.

Who may be able to join

  • age between 18 and 75 years,
  • written informed consent to participate in the study
  • one of following surgeries: mitral valve surgery with CPB, resection of pulmonary metastases with OLV, or minimally invasive mitral valve surgery with CPB and OLV.

Who cannot join

  • chronic respiratory insufficiency
  • history of pulmonary resection or pneumonectomy
  • pulmonary thromboembolism
  • lung injury
  • severe peripheral arterial disease
  • emergency surgery
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Paula Ortiz Lucas, M.D. contact

paula.ortiz.lucas@uniklinik-freiburg.de

Germany1 site, 1 recruiting
  • Departement of Anaesthesiology and Critical Care Medicine, University Medical Center

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Torsten Loop, MD,Professor

    Paula Ortiz Lucas, M.D.

    Recruiting

Other trials in Germany

About this study

Official title: Extravascular Lung Water Index and Pulmonary Vascular Permeability Index Assessed by the Transpulmonary Thermodilution Method in Patients After Minimally Invasive Cardiac Surgery With Cardiopulmonary Bypass and One Lung Ventilation

The use of cardiopulmonary bypass (CPB) combined with one lung ventilation (OLV) allows to perform minimally invasive cardiac surgery (MICS) through small incisions. MICS is described to be associated with similar outcomes compared with conventional surgery. Although less invasive, MICS has not been reported to favorably impact the incidence of respiratory failure after surgery.

The combination CPB and OLV may induce acute respiratory distress syndrome (ARDS). After CPB contact of blood components with the artificial surface of the bypass, lung ischemia reperfusion injury (LIRI) and operative trauma may trigger a systemic inflammatory response syndrome (SIRS). During OLV, ARDS can result from hyperoxia, hyperperfusion and ventilatory distress in the ventilated lung as well as from LIRI and operative trauma of the collapsed lung.

Read more

Extravascular lung water (EVLW) includes all fluids in the lung except for those in the vascular compartment. An excess of EVLW may lead to respiratory insufficiency. This may be due to an increased hydrostatic intravascular pressure, as it occurs in cardiogenic pulmonary edema, and/or by an increase of lung endothelial and epithelial permeability, as in ARDS. The extravascular lung water index (EVLWI) assessed by the transpulmonary thermodilution technique may be a useful tool for accurate diagnosis of ARDS, and the pulmonary vascular permeability index (PVPI) may help in the differentiation between pulmonary edema due to an increase in the pulmonary capillary permeability versus an increase in the pulmonary capillary hydrostatic pressure.

As both CPB and OLV may induce an excess of EVLW, the investigators hypothesize that patients after MICS with intraoperative combination of CPB and OLV may have higher EVLWI and PVPI than those who received either CPB or OLV alone.

Read the detailed description

Acute respiratory distress syndrome (ARDS) occur with an incidence of 12% after cardiac surgery with the use of cardiopulmonary bypass (CBP). Using one-lung ventilation (OLV) in addition, as it is common practice in minimally invasive cardiac surgery (MICS), one can hypothesize that the risk for ARDS increases.

The objective of this prospective, observational study is to measure extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) as parameters of lung edema through alteration in the pulmonary permeability by comparing three groups of surgery patients: I) patients with CPB, II) patients with OLV and III) patients with both CPB and OLV.

MICS allows coronary artery bypass grafting and cardiac valve surgery through small incisions, does not appear to be inferior to conventional surgery, but likely reduces postoperative pain, accelerates postoperative recovery and improves the cosmetic result. However, based on the available data, respiratory failure after MICS occurs at the same rate as after conventional cardiac surgery. In addition, unilateral re-expansion pulmonary edema, rarely seen after conventional cardiac surgery, has been described after MICS with CPB and OLV.

The pathophysiology of ARDS is characterized by massive inflammation that leads to a diffuse damage of both the alveolar epithelium and pulmonary vascular endothelium. Although the etiology of ARDS is multifactorial, the uniform result is an acute, nonhydrostatic, high-permeability lung injury with interstitial and alveolar protein-rich edema, epithelial damage and rapid onset of pulmonary fibrosis. This leads to the vast reduction of the pulmonary gas exchange and to hypoxemia.

Extravascular lung water (EVLW) comprises all fluids of the extravascular compartment of the lung, ie, intracellular water, lymphatic fluid, surfactant and extravasated plasma. Increased EVLW may be caused by an increased hydrostatic intravascular pressure, as it occurs in cardiogenic pulmonary edema, and/or by an increase of lung endothelial and epithelial permeability, as in ARDS. The EVLWI estimates the EVLW by using the transpulmonary thermodilution technique.The pulmonary vascular permeability index (PVPI) is the ratio between the EVLWI and the pulmonary blood volume, which is also measured by the transpulmonary thermodilution technique. The PVPI is thought to reflect the permeability of the alveolar-capillary barrier.

The combination of CPB and OLV permitted the development of MICS. CPB is an extracorporeal circulation, where a heart-lung machine takes over temporarily the pump function of the heart and the oxygenation and ventilation function of the lungs, thereby, allowing various heart and vascular surgical procedures. During CPB, blood from the right side of the heart is drained into the heart-lung machine and returned into the arterial system. This leads to a hypoperfusion of the lung, while blood flow is maintained only through the bronchial artery. OLV allows the surgeon to access the thorax cavity for the operation, while contralateral lung is ventilated.

It was originally thought that the lung is relatively resistant to ischemia due to its dual circulation. However, re-perfusion of the lung after CPB and/or OLV can trigger a fatal cascade, summarized as lung ischemia reperfusion injury (LIRI). LIRI involves intracellular injury and pertinent inflammatory responses, which result in apoptosis of the endothelium, alveolar capillary interstitial edema, hyaline membranization, and infiltration by neutrophils and macrophages. In addition, during CPB, the contact of blood components with the artificial surface of the bypass circuit contribute to the postoperative systemic inflammatory response syndrome (SIRS). Through these mechanisms, lung compliance and resistance as well as pulmonary permeability are affected, which contributes to the development of ARDS. During OLV, a combination of LIRI as well as surgical trauma and lung hyperinflation may lead to the release of inflammatory mediators which can alter endovascular permeability. Additionally, after thoracic surgery the pulmonary vascular permeability increases and re-expansion of the collapsed lungs may result in the so called re-expansion pulmonary edema.

To the best of the investigators knowledge, no study primarily aimed at examining the relationship between MICS and lung injury, although it is of high clinical interest whether the combination of CPB and OLV during MICS leads to increased EVLW and pulmonary permeability and ARDS.

Keywords
EVLW, EVLWI, PVPI, MICS
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02155387
Study groupRoleWhat they receive
Coronary artery bypass graft surgerywith cardiopulmonary bypass
Pulmonary metastasectomy by thoracotomywith one lung ventilation
Minimal invasive mitral valve surgerywith cardiopulmonary bypass and one lung ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extravascular lung water index (EVLWI) measured by a Pulse Contour Cardiac Output (PiCCO©) system device

    EVLWI (ml/Kg) will be assessed after the induction of general anesthesia but before the surgery starts. This observational point is defined as T0. The observational time points T1, T2, T3 and T4 are 30 minutes, 6 hours, 12 hours and 24 hours, respectively, after stop of OLV and/or CPB. In case of OLV, an observational time point (Ta) will be added 15 minutes after start of the OLV. In patients with CPB and OLV, an additional time point (Tb) is 15 minutes after stop of the CPB while still under OLV.

    Measured: T0= baseline; Ta= 15 minutes after start of the OLV; Tb=15 minutes after stop of the CPB while still under OLV; 30 minutes (T1), 6 hours (T2), 12 hours (T3) and 24 hours (T4) after stop of OLV and/or CPB.

  2. Pulmonary vascular permeability index (PVPI) measured by a Pulse Contour Cardiac Output (PiCCO©) system device

    PVPI will be assessed after the induction of general anesthesia but before the surgery starts. This observational point is defined as T0. The observational time points T1, T2, T3 and T4 are 30 minutes, 6 hours, 12 hours and 24 hours, respectively, after stop of OLV and/or CPB. In case of OLV, an observational time point (Ta) will be added 15 minutes after start of the OLV. In patients with CPB and OLV, an additional time point (Tb) is 15 minutes after stop of the CPB while still under OLV.

    Measured: T0, T1, T2, T3, T4, Ta, Tb

Secondary outcomes (1)
  1. Any respiratory problem that the patient had during the postoperative period in the intensive care unit

    One month after the surgery, any respiratory problem, such as infiltrate, atelectasis, pleural fluid, pneumonia or ARDS, that the patient had during the postoperative recovery period in the intensive care unit (ICU) will be assessed based on the medical records. Chest radiograph will be reviewed to assess the presence of infiltrates, atelectasis, pleural fluid and pulmonary edema. The pneumonia diagnosis will be based on the presence of pulmonary infiltrates and laboratory results. The Berlin definition will be used to establish the diagnosis of ARDS.

    Measured: one month after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2015 (estimated)
  4. Study completionApr 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02155387
Sponsor's protocol ID
MICSLUWA2014
Status last verified
Jun 2014
First submitted
23 Apr 2014
Last updated
4 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome, run by University Hospital Freiburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Torsten Loop, MD,Professor (+ 49 761 270 23060, torsten.loop@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extravascular lung water index (EVLWI) measured by a Pulse Contour Cardiac Output (PiCCO©) system device (time frame: T0= baseline; Ta= 15 minutes after start of the OLV; Tb=15 minutes after stop of the CPB while still under OLV; 30 minutes (T1), 6 hours (T2), 12 hours (T3) and 24 hours (T4) after stop of OLV and/or CPB.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.

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