A comparative study to assess the effect of interventions to prevent lung damage during anaesthesia, on postoperative lung complications after lung cancer surgery.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2023/10/058887
- Lead Sponsor
- Tata Memorial Hospital Mumbai India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age between 18-80 years
2.Patients scheduled for open thoracic or video-assisted thoracoscopic or robot-assisted lung resection onco-surgery which would involve planned resection of at least one lobe of the lung.
3.The planned duration of surgery is more than 60 minutes.
1.Patients with documented evidence of chronic obstructive pulmonary disease (COPD) GOLD grades III and IV, interstitial lung disease with a GAP index >4, documented bullae (occupying more than one-third of the hemithorax).
2.Patients with uncontrolled asthma
3.patients with heart failure New York Heart Association grade 3 and 4 or coronary heart disease, showing a positive stress test or inducible ischemia on stress echocardiography;
4.patients with previous lung surgery;
5.patients with at-rest documented mean pulmonary arterial pressure > 25 mmHg, or systolic pulmonary arterial pressure > 35 mmHg (as estimated by echocardiography);
6.patients with documented or suspected neuromuscular disease (e.g., thymoma, myasthenia, myopathies, muscular dystrophies);
7. patients who are planned for mechanical ventilation after surgery prior to anaesthesia induction;
8. Patients who are planned for bilateral procedures;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a collapsed composite of all Postoperative Pulmonary Complications developing during the hospital stay till the time of discharge.Timepoint: a collapsed composite of all Postoperative Pulmonary Complications developing during the hospital stay till the time of discharge.
- Secondary Outcome Measures
Name Time Method 1.Incidence of intra-operative complications, defined as- <br/ ><br>•Hypoxemia that required the use of rescue manouvres (one or more than one) <br/ ><br>•Hypotension unresponsive to fluids and/or vasoactive drugs, <br/ ><br>•Occurrence of new arrhythmias <br/ ><br>•Need for infusion of vasoactive drugs (mephentermine > 15 mg and/ or noradrenaline and/or adrenaline and/or dobutamine and /or vasopressin and/or any intravenous vasodilator drugs) to maintain BP within normal ranges <br/ ><br>•Drop in urine output less than 0.5 ml/kg/hour for 6 consecutive hours <br/ ><br>•Occurrence of bronchospasm that require administration of inhaled or parenteral bronchodilators or steroids. <br/ ><br>2. Duration of post-operative hospital stay- from day of surgery (considered as day 0 to the day of discharge from the hospital) <br/ ><br>3. 30- day mortality- All causes of mortality within 30 days of surgery. <br/ ><br>Timepoint: at the time of discharge from the hospital.