ess inspiration- expiration during operation in the belly in patients with infection in the belly
- Conditions
- Health Condition 1: null- Adult patients with intraabdominal infection undergoing laparotomy
- Registration Number
- CTRI/2017/12/010732
- Lead Sponsor
- Dr Dalim Kumar Baidya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age between 18 and 70 years
Emergency laparotomy expected duration >2 hours and < 5 hours
Peritonitis (suspected or identified abdominal source of infection) of less than 5 days duration
Preoperative risk index for pulmonary complications >2
1. Mechanical ventilation within 2 weeks preceding surgery
2. BMI >= 35, < 18
3. History of respiratory failure or sepsis within the 2 weeks preceding surgery
4. Requirement for intrathoracic surgery, history of lung surgery
5. History of smoking or COPD, with (non-invasive) ventilation and/or oxygen therapy at home and/or repeated systemic corticosteroid therapy for acute exacerbations of COPD
6. Progressive neuromuscular illness
7. ALI or acute respiratory distress syndrome expected to require prolonged post-operative mechanical ventilation,
8. Persistent hemodynamic instability or intractable shock
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary complications occurring up to day 7 after surgery <br/ ><br> <br/ ><br>1. Acute respiratory failure <br/ ><br> <br/ ><br>Mild respiratory failure responding to supplemental oxygen <br/ ><br> <br/ ><br>Severe respiratory failure requiring invasive or noninvasive mechanichal ventilation <br/ ><br> <br/ ><br>2. Pneumonia <br/ ><br> <br/ ><br>3. ARDS <br/ ><br> <br/ ><br>4. PneumothoraxTimepoint: Pulmonary complications occurring up to day 7 after surgery <br/ ><br> <br/ ><br>1. Acute respiratory failure <br/ ><br> <br/ ><br>Mild respiratory failure responding to supplemental oxygen <br/ ><br> <br/ ><br>Severe respiratory failure requiring invasive or noninvasive mechanichal ventilation <br/ ><br> <br/ ><br>2. Pneumonia <br/ ><br> <br/ ><br>3. ARDS <br/ ><br> <br/ ><br>4. Pneumothorax
- Secondary Outcome Measures
Name Time Method 1. Pulmonary complications graded on a scale 0 to 410 <br/ ><br> <br/ ><br>2. Ventilation related adverse events during surgery <br/ ><br> <br/ ><br>3. Severe sepsis, septic shock, organ dysfunction <br/ ><br> <br/ ><br>4. Number of days of ICU admission and duration of hospital stay <br/ ><br> <br/ ><br>5. Surgical complications <br/ ><br> <br/ ><br>6. Pre and postoperative serum IL 6, IL 8, and TNFα â?? first sample will be obtained at the beginning of surgery and second sample will be obtained at 24 hoursTimepoint: Till the discharge