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A comparative study to assess the effect of interventions to prevent lung damage during anaesthesia, on postoperative lung complications after lung cancer surgery.

A randomized controlled, double blinded study to test the efficacy of Protective One Lung Ventilation Bundle in prevention of Post Operative Pulmonary Complications following elective major lung resection surgeries in a tertiary care cancer institute. - P-OLV

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058887
Enrollment
319
Registered
2023-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Protective one lung ventilation bundle: 1. Recruitment of the ventilated lung at 20cm H2O for 20 seconds (provided mean arterial pressure is within 30 percent of baseline). 2. Before de

Sponsors

Tata Memorial Hospital Mumbai India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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;

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Incidence of intra-operative complications, defined as- ? Hypoxemia that required the use of rescue manouvres (one or more than one) ? Hypotension unresponsive to fluids and/or vasoactive drugs, ? Occurrence of new arrhythmias ? 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 ? Drop in urine output less than 0.5 ml/kg/hour for 6 consecutive hours ? Occurrence of bronchospasm that require administration of inhaled or parenteral bronchodilators or steroids. 2. Duration of post-operative hospital stay- from day of surgery (considered as day 0 to the day of discharge from the hospital) 3. 30- day mortality- All causes of mortality within 30 days of surgery. Timepoint: at the time of discharge from the hospital.

Countries

India

Contacts

Public ContactDr Sumona Kundu

Tata Memorial Hospital

swapnil.parab@gmail.com9819319866

Outcome results

None listed

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