Oesophageal cancer Cancer Malignant neoplasm of the oesophagus
Conditions
Interventions
Inhaled salmeterol (100 µg) via spacer immediately prior to surgery, and then afterwards twice daily for 72 hours, versus placebo inhaler. If the patient is ventilated the drug will be given through t
Sponsors
Birmingham Heartlands Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Planned elective transthoracic oesophagectomy patients 2. Aged greater than 18 years 3. Male and female 4. Able to provide informed consent 5. Able to use a spacer device to deliver the drug
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Current treatment with long acting beta agonist 3. Allergy to excipients in salmeterol 4. Current treatment with non-cardioselective beta-blockers 5. Treatment with investigational medicinal product (IMP) in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development of clinically significant acute lung injury within 72 hours of oesophagectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global severity of illness at admission to Intensive Therapy Unit (ITU): Acute Physiology And Chronic Health Evaluation (APACHE II) 2. Severity of respiratory illness (partial pressure of oxygen in arterial blood [PaO2]:Fraction of inspired Oxygen [FiO2] ratio) daily for duration of intensive care unit (ITU)/high dependency unit (HDU) stay 3. Development of acute lung injury/acute respiratory distress syndrome (ARDS) at day 0 - 28 4. Ventilator free days 5. Organ failure free days 6. 28 and 90 day survival 7. Health related quality of life (EQ-5D) at baseline and at 28 and 90 days | — |
Countries
United Kingdom
Outcome results
None listed