Anesthesia Clinical Trial
Official title:
Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study
Verified date | June 2007 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction in extravascular lung water | within the first 24 hours after lung surgery | ||
Secondary | changes in oxygenation indices, hemodynamics and radiological lung injury score | within the first 48 hours |
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