Prevention of Lung Edema After Thoracic Surgery

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Background :

Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad prognosis with a high mortality rate ranging from 20 to 100%.

Objectives :

1. to evaluate pre-, intra- and postoperative changes in hemodynamics, oxygenation indices as well as intra- and extravascular lung water using simple thermodilution technique and continuous arterial pressure analysis

2. to test the efficacy of inhaled beta2 -adrenergic agonist versus anticholinergic agents to reduce lung edema in patients undergoing thoracic surgery and in pigs subjected to lipolysacharide-induced ALI.

Design of the research protocol:

• Prospective controlled trial including surgical patients with high risk factors for ALI (n=60) allocated to receive inhaled drugs (randomised, double-blind, cross-over mode).

• Main measurements:

Intra-thoracic blood volume, intra- and extra-vascular lung water, hemodynamic parameters (CO, systolic arterial pressure/flow variations, dPmax, MAP, CVP), oxygenation indices (PaO2/FIO2), ventilatory parameters, clinical outcome data, histochemical and pathological data.

Glossary CO = cardiac output; dPmax = maximal arterial pressure slope; SAP-V = systolic arterial pressure variations; Flow-V = Flow variations; MAP = mean arterial pressure; CVP = central venous pressure; PaO2=arterial oxygen pressure; FIO2= oxygen inspiratory fraction

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Albuterol; Ipratropium

Criteria

Inclusion Criteria:

Patients with at least 3 risk factors for postoperative lung edema

• age > 60 yrs

• history of chronic alcohol consumption (>60g/day)

• prior radiation or chemotherapy

• cardiac insufficiency (left ventricular ejection fraction < 40%, or a history of past acute heart failure)

• coronary artery disease (history of myocardial infarct, Q wave on the ECG, positive stress test or coronary angiogram)

• recent pneumonia (within 6 weeks of hospital admission)

• reduced diffusion capacity for carbon monoxide (DLCO < 60% of predicted values)

• predicted postoperative lung perfusion of < 55% of total lung perfusion

Exclusion Criteria:

• pneumonectomy

• intracardiac shunts

• valvular diseases

• aortic abdominal aneurysm

• chronic treatment with inhaled bronchodilators

• a history of any adverse reaction to bronchodilators

• liver or kidney insufficiencies