Prevention of Lung Edema After Thoracic Surgery
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|ClinicalTrials.gov Identifier: NCT00498251|
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
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
|Condition or disease||Intervention/treatment||Phase|
|Lung Injury, Acute Thoracotomy Anesthesia Intensive Care, Surgical Extravascular Lung Water||Drug: inhalation of salbutamol (5 mg) Drug: ipratropium||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study|
|Study Start Date :||September 2004|
|Actual Study Completion Date :||June 2007|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498251
|University Hospital of Geneva|
|Geneva, Switzerland, CH-1211|
|Principal Investigator:||Christoph Ellenberger, MD||University Hospital, Geneva|