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Prevention of Lung Edema After Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498251
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
Information provided by:
University Hospital, Geneva

Brief 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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. reduction in extravascular lung water [ Time Frame: within the first 24 hours after lung surgery ]

Secondary Outcome Measures :
  1. changes in oxygenation indices, hemodynamics and radiological lung injury score [ Time Frame: within the first 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00498251

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University Hospital of Geneva
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Christoph Ellenberger, MD University Hospital, Geneva
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00498251    
Other Study ID Numbers: CER03-160
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: June 2007
Keywords provided by University Hospital, Geneva:
lung injury, acute
thoracic surgical procedures
lung cancer
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents