Clinical trial · Interventional
Prevention of Lung Edema After Thoracic Surgery
Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Extravascular Lung Water | — | UNRESOLVED | — |
| Intensive Care, Surgical | — | UNRESOLVED | — |
| Lung Injury, Acute | — | UNRESOLVED | — |
| Thoracotomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inhalation of salbutamol (5 mg) | Drug | — | UNRESOLVED |
| ipratropium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- reduction in extravascular lung water
- timeFrame
- within the first 24 hours after lung surgery
Secondary outcomes (1)
- measure
- changes in oxygenation indices, hemodynamics and radiological lung injury score
- timeFrame
- within the first 48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLicker M, Tschopp JM, Robert J, Frey JG, Diaper J, Ellenberger C. Aerosolized salbutamol accelerates the resolution of pulmonary edema after lung resection. Chest. 2008 Apr;133(4):845-52. doi: 10.1378/chest.07-1710. Epub 2007 Nov 7. PMID 17989152