Prevention of Lung Edema After Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00498251
First received: July 6, 2007
Last updated: July 9, 2007
Last verified: June 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498251

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

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00498251     History of Changes
Other Study ID Numbers: CER03-160
Study First Received: July 6, 2007
Last Updated: July 9, 2007
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014