PATIENT CHARACTERISTICS AND PREOPERATIVE DATA (ecrf 1).

Transcription

1 PATIENT CHARACTERISTICS AND PREOPERATIVE DATA (ecrf 1). 1 Inform Consent Date: / / dd / Mmm / yyyy 2 Patient identifier: Please enter the 6 digit Patient identification number from your site patient log sheet 3 Gender: Male Female 4 Date of birth: / / dd / Mmm / yyyy 5 In-Hospital admission: / / dd / Mmm / yyyy 6 Weight: in kilograms (Kg.) 7 Height: in meters (m.) decimal is indicated with a dot 8 Functional Status 1= Independent; 2= Partially dependent; 3= Totally dependent Partially dependent or totally dependent defined as the partial or total need for help in performing activities of daily living 9 Chronic Obstructive Pulmonary Disease (COPD) 1=yes; 2=No Answer yes or no to the question Has any physician told you that you have a chronic respiratory disease, such as chronic bronchitis or emphysema? 10 Respiratory Symptoms: 0= No symptoms 1=1 symptom 2=2 symptoms 3=3 symptoms 4=4 symptoms Cough: do you have daily cough at least during 3 month per year? Sputum production: do you have daily sputum at least during 3 month per year? Wheezing: did you ever have wheezing? Dyspnea:do you breath with difficulty with exercise? 11 Smoking Status: 1=Never smoker 2=Current smoker 3=Former smoker (withdrawn more than 1 month ago) Never smoker: has never smoked cigarettes or smoked less than 1 cigarette/d or has smoked fewer than 100 cigarettes ever Former smoker: smoked regularly 1 cigarette/d or more, or smoked more than 100 cigarettes over a lifetime, and quit at least 15 days before the operation Current smoker: regularly smokes at least 1 cigarette/d as of at least 1 month before the operation 12 Lifetime smoking exposure: pack-year Lifetime smoking exposure (1 pack-year = 20 cigarettes/d for 1 year or 10 cigarettes/d for 2 years), accumulated during lifetime independently of the current smoking status.

2 13 Respiratory infection in the last month: 1=yes; 2=No Answer yes or no to the question Have you had an acute respiratory illness, with fever that needed to be treated with antibiotics, within the last month? 14 Cough test: 1=positive; 2=negative Not done The patient is told to take a deep breath and cough once. A positive test is defined by repeated coughing after the first cough 15 Preoperative SpO2 (oxyhemoglobin saturation by pulse oximetry): % Not done Preoperative oxyhemoglobin saturation by pulse oximetry breathing air in supine position (SpO2): SpO2 is recorded in supine position after 1 minute resting breathing air, or in patients on oxygen, after 10 min without oxygen. If SpO2 reach a value of 88% oxygen will be administered and the minimum value will recorded. 16 Preoperative Haemoglobin: in g/dl. The latest value before surgery Not Available 17 History of Heart Failure 0= No 1=NYHA 1 2=NYHA 2 3=NYHA 3 4=NYHA 4 Heart failure (New York Heart Association Scale of I or higher) 18 Hypertension: 1=yes; 2=No declared by the patient or recorded in the chart 19 Coronary Artery disease: 1=yes; 2=No (history of myocardial infarction or angina) 20 Neurologic disease: 1=yes; 2=No (definite motor, sensory, or cognitive dysfunction 21 Liver disease: 1=yes; 2=No (previous jaundice, hepatomegaly or ascites 22 Renal disease: 1=yes; 2=No preoperative serum creatinine >2 mg/dl 23 Preoperative creatinine in mg/dl Not available 24 American Society Anesthesiologists (ASA) physical Status: 1=1 2=2 3=3 4=4

3 DETAILS OF SURGERY AND INTRAOPERATIVE DATA (ecrf 2) 1 Date of Surgery: / / dd / Mmm / yyyy 2 Operation: coded by ICD (WHO) 2A Second operation coded by ICD (WHO) 3 Surgical Specialty: 1=Orthopaedics 2=General and Digestive 3=Urology 4=Gynaecology 5=ENT 4 Type of Surgery: 1=scheduled 2=emergency 6=Vascular 7=Breast 8=Cardiac 9=Thoracic 10=Neurosurgery 11=Others 5 Surgical incision: 1= Intrathoracic open (thoracotomy or sternotomy); 2= Intrathoracic closed (thoracoscopy or mediastinoscopy); 3= Upper abdominal open (subcostal or median supraumbilical laparotomy); 4= Upper abdominal closed (subcostal or supraumbilical laparoscopic approach); 5=Peripheral and other incisions 6A Time of Surgical incision : hh: mm (in a 24 hr basis) 6B Time of closing incision : hh: mm (in a 24 hr basis) 7 Anaesthetic technique: 1=General alone 2=General with neuroaxial blockade 3=General with plexus block 4=Neuroaxial blockade 5=Plexus block. 8 Intraoperative blood transfusion: Number of units of packed red blood cells transfused 9 Crystalloids: Liters infused (L.) 10 Colloids: Liters infused (L.)

4 POSTOPERATORY PULMONARY COMPLICATIONS (ecrf 3) 1 Has subject experienced any Postoperative pulmonary complications (PPCs)? 1=yes; 2=No (If No please go to item 21) 2 Respiratory failure: 1=No; 2=Mild; 3=Intermediate; 4= Severe (ALI/ARDS) 2- Mild: PaO 2 < 60 mmhg or SpO 2 < 90% in room air but responding to mask/nasal supplemental oxygen (excluding hypoventilation) 3- Intermediate: Need for non invasive or invasive mechanical ventilation due to a PaO2 < 60 mmhg or SpO2 < 90% 4- Severe (ALI/ARDS): Need for invasive mechanical ventilation and PaO2/ FiO2 <300 mmhg regardless the level of PEEP 3 Date of diagnosis of respiratory failure / / dd / Mmm / yyyy 4 Suspected pulmonary infection: 1=yes; 2=No Answer YES if patient receives antibiotics and meets at least one of the following criteria: new or changed sputum, new or changed lung opacities on chest X ray when clinically indicated, temperature > 38 0 C, leukocytosis > 12,000/ l 5 First date of postoperative suspected pulmonary infection / / dd / Mmm / yyyy 6 Suspected Pulmonary infiltrate 1=yes; 2=No Chest X ray demonstrating monolateral or bilateral opacities 7 First date of postoperative suspected pulmonary infiltrate / / dd / Mmm / yyyy 8 Pleural effusion 1=yes; 2=No Chest X ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemi thorax with preserved vascular shadows 9 First date of evidence of pleural effusion / / dd / Mmm / yyyy 10 Atelectasis 1=yes; 2=No Suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory overinflation in the adjacent nonatelectatic lung 11 First date of atelectasis diagnosis / / dd / Mmm / yyyy 12 Aspiration pneumonitis 1=yes; 2=No Defined as respiratory failure after the inhalation of regurgitated gastric contents

5 13 Date of evidence of aspiration pneumonitis / / dd / Mmm / yyyy 14 Bronchospasm: 1=yes; 2=No Defined as newly detected expiratory wheezing treated with bronchodilators 15 Date of bronchospasm / / dd / Mmm / yyyy 16 Pneumothorax: 1=yes; 2=No Defined as air in the pleural space with no vascular bed surrounding the visceral pleura 17 Date of pneumothorax diagnosis: / / dd / Mmm / yyyy 18 Cardiogenic pulmonary oedema: 1=yes; 2=No Defined as diffuse alveolar interstitial infiltrates with dyspnoea and rales related to left ventricular failure, confirmed by one of the following: echocardiography, pulmonary catheter monitoring or clinical improvement with specific treatment 19 Date of diagnosis of cardiogenic pulmonary oedema : / / dd / Mmm / yyyy 20 Accumulated hours of postoperative ICU (in hours) 21 Discharged from hospital: 1=Alive, to home; 2=Alive, to acute centre; 3=Alive, to Convalescent/Nursing Home; 4=Death 22 Date of discharge: / / dd / Mmm / yyyy 23 Cause of death: According to ICD 9 WHO Classification