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Clinical Trials/NCT02155387
NCT02155387UnknownNot Applicable

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

University Hospital Freiburg1 site in 1 country30 target enrollmentStarted: April 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Extravascular lung water index (EVLWI) measured by a Pulse Contour Cardiac Output (PiCCO©) system device

Study Overview

Brief 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. 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.

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

Time Frame: T0, T1, T2, T3, T4, Ta, Tb

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.

Secondary Outcomes

  • Any respiratory problem that the patient had during the postoperative period in the intensive care unit(one month after the surgery)

Investigators

Sponsor
University Hospital Freiburg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Torsten Loop

M.D., Professor

University Hospital Freiburg

Study Sites (1)

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