SV vs. PPV for lung biopsy under GA in patients with ILD
Research type
Research Study
Full title
Effect of spontaneous ventilation versus positive pressure ventilation in patients undergoing diagnostic thoracoscopic biopsy for Interstitial Lung Disease (ILD) under General Anaesthesia (GA).
IRAS ID
184866
Contact name
Guillermo Martinez-Munoz
Contact email
Sponsor organisation
Papworth Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
Interstitial lung disease is a devastating, progressive respiratory condition, that causes scarring of the lung tissue and impairment of oxygen uptake and carbon dioxide excretion. It is incurable, and most treatments are of use only in slowing disease progression.
Patients with Interstitial Lung Disease ILD whom require mechanical ventilation for respiratory failure demonstrate high in-hospital mortality. It is thought that the positive pressure required for mechanical ventilation accelerates the lung fibrosis and scarring associated with the disease.
Surgical lung biopsy is required in 33% of patients with ILD to establish a diagnosis and inform patient management. However, this procedure traditionally requires mechanical ventilation as part of the anaesthetic.
It is known that lung biopsy has an average 30-day mortality of 3.8% (2.1 – 5.5%) , mostly from progressive respiratory failure. Given the we know that mechanical ventilation worsens ILD, avoidance could improve patient outcomes.
Recently, a variety of different anaesthetic techniques have been developed to allow patients to maintain their own breathing during lung biopsy, and avoid mechanical ventilation and analysed, predominantly through case series. These studies show spontaneous ventilation, with and without general anaesthesia is feasible, with comparable morbidity and mortality to traditional mechanical ventilation approaches. No study has yet performed a prospective validation of spontaneous against mechanical ventilation for patients undergoing lung biopsy for diagnosis of ILD.
We propose a pilot Randomised Controlled Trial to compare spontaneous ventilation through a Supraglottic Airway (SAG) under general anaesthesia to the current standard of mechanical ventilation through a tube in the trachea in patients undergoing lung biopsy for ILD. We hope to prove that using spontaneous ventilation rather than mechanical ventilation leads to fewer days in hospital and greater survival after one month, and improved lung function six months after the procedure.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0398
Date of REC Opinion
15 Oct 2015
REC opinion
Further Information Favourable Opinion