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Prevention of Lung Edema After Thoracic Surgery

This study has been completed.
Information provided by:
University Hospital, Geneva Identifier:
First received: July 6, 2007
Last updated: July 9, 2007
Last verified: June 2007

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 Intervention
Lung Injury, Acute Thoracotomy Anesthesia Intensive Care, Surgical Extravascular Lung Water Drug: inhalation of salbutamol (5 mg) Drug: ipratropium

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

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

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

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: June 2007
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00498251

University Hospital of Geneva
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Christoph Ellenberger, MD University Hospital, Geneva
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00498251     History of Changes
Other Study ID Numbers: CER03-160
Study First Received: July 6, 2007
Last Updated: July 9, 2007

Keywords provided by University Hospital, Geneva:
lung injury, acute
thoracic surgical procedures
lung cancer

Additional relevant MeSH terms:
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 processed this record on September 25, 2017