Beta Agonist Lung injury Trial - Prevention Study

INTERVENTION: Trade Name: Salmeterol Product Name: Salmeterol Pharmaceutical Form: Inhalation vapour, powder INN or Proposed INN: SALMETEROL CAS Number: 89365504 Concentration unit: µg microgram(s) Concentration type: range Concentration number: 50‐100 Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: This programme of research will examine the role of beta‐2 agonist as specific pharmacotherapy to reduce the incidence of Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS) in patients undergoing elective oesophagectomy. PRIMARY OUTCOME: Main Objective: Acute respiratory distress syndrome (ARDS) is a serious condition affecting the lungs, making it difficult for the lungs to work effectiveley and get oxygen into the blood. ARDS also complicates approximately 25‐30% of patients undergoing oesophagectomy (procedure to remove a portion of the lower gullet). This study aims; to evaluate whether prophylactic (preventive) treatment with inhaled salmeterol will reduce the incidence of; ARDS in patients undergoing elective oesophagectomy. Primary end point(s): The primary outcome will be the development of clinically significant acute lung injury within 72 hours of oesophagectomy. Secondary Objective: ‐To evaluate the effects of Salmeterol on:; ‐global severity of illness(APACHE II, SAPS II, SOFA); and respiratory severity of illness (oxygenation [PaO2:FiO2 ratio,lung injury score, lung water, [day 0 ‐ extubation]); ‐lung and systemic inflammation.; ‐To evaluate the ALI/ARDS within 28 days of surgery; 60 day and 1 year mortality.; ‐To evaluate the effects of salmeterol on the number of days a patient is not on a ventilator. INCLUSION CRITERIA: 1. Provision of informed consent. 2. Age >18years. 3. Planned elective transthoracic oesophagectomy. 4. Ability to use inhaler with spacer device. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range