Prevention of Lung Edema After Thoracic Surgery
Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad prognosis with a high mortality rate ranging from 20 to 100%.
- 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
- 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
Lung Injury, Acute
Intensive Care, Surgical
Extravascular Lung Water
Drug: inhalation of salbutamol (5 mg)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study|
- reduction in extravascular lung water [ Time Frame: within the first 24 hours after lung surgery ]
- changes in oxygenation indices, hemodynamics and radiological lung injury score [ Time Frame: within the first 48 hours ]
|Study Start Date:||September 2004|
|Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498251
|University Hospital of Geneva|
|Geneva, Switzerland, CH-1211|
|Principal Investigator:||Christoph Ellenberger, MD||University Hospital, Geneva|