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Less inspiration- expiration during operation in the belly in patients with infection in the belly

Intraoperative lung protective ventilation in peritonitis patients undergoing emergency laparotomy: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010732
Enrollment
100
Registered
2017-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Adult patients with intraabdominal infection undergoing laparotomy

Interventions

Intervention1: Lung protective ventilation: protective lung ventilation with tidal volume 6 to 8ml/kg and PEEP 6 to 8cm H2O, along with recruitment maneuvers (30 cm H2O for 30 seconds) every half hour

Sponsors

Dr Dalim Kumar Baidya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years Emergency laparotomy expected duration >2 hours and Peritonitis (suspected or identified abdominal source of infection) of less than 5 days duration Preoperative risk index for pulmonary complications >2

Exclusion criteria

Exclusion criteria: 1. Mechanical ventilation within 2 weeks preceding surgery 2. BMI >= 35, 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

Design outcomes

Primary

MeasureTime frame
Pulmonary complications occurring up to day 7 after surgery 1. Acute respiratory failure Mild respiratory failure responding to supplemental oxygen Severe respiratory failure requiring invasive or noninvasive mechanichal ventilation 2. Pneumonia 3. ARDS 4. PneumothoraxTimepoint: Pulmonary complications occurring up to day 7 after surgery 1. Acute respiratory failure Mild respiratory failure responding to supplemental oxygen Severe respiratory failure requiring invasive or noninvasive mechanichal ventilation 2. Pneumonia 3. ARDS 4. Pneumothorax

Secondary

MeasureTime frame
1. Pulmonary complications graded on a scale 0 to 410 2. Ventilation related adverse events during surgery 3. Severe sepsis, septic shock, organ dysfunction 4. Number of days of ICU admission and duration of hospital stay 5. Surgical complications 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

Countries

India

Contacts

Public ContactDr Dalim Kumar Baidya

All India Institute of Medical Sciences, New Delhi

dalimkumarb001@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026