Regulatory, Quality, and Technical Aspects in Clinical Sampling for Early Detection of Pneumonia in Ventilated Patients

Irit Segalovich, Clinical operations, Respiration Scan, Kfar Shmuel, Israel (s_irit@012.net.il)

This lecture focuses on the specialized regulatory, quality, and technical considerations involved in a clinical trial conducted by Respiration Scan Ltd., which has developed an innovative method for the early detection of pneumonia in mechanically ventilated patients. The technique measures volatile organic compounds (VOCs) in exhaled air returning from the patient's lungs, allowing for the assessment of bacterial infection levels in the respiratory system.

The trial includes a meticulous sampling protocol, in which each patient is sampled using two sampling units, sequentially numbered to maintain order and traceability. Accurate documentation is a cornerstone of this process, ensuring the correct identification of the patient, the ventilator, and the respective samples. This precision is critical to prevent errors that could compromise patient safety or data integrity.

In addition to VOC sampling, a tracheal lavage specimen is collected in parallel for laboratory analysis at both the hospital and Respiration Scan's facilities. This dual sampling approach introduces additional logistical challenges, including the transport, cooling, and precise registration of samples. Maintaining the integrity of the samples requires proper preservation under controlled conditions, as well as reliable tracking systems to monitor their status and ensure their availability for analysis.

An additional layer of complexity arises from the requirement to obtain informed consent from the ventilated patients and/or their families before participation in the clinical trial. This process involves sensitive and ethical considerations, requiring clear communication and respect for the patients’ rights and the unique challenges posed by their medical conditions.

The lecture will provide a detailed discussion of these complex sampling methodologies, emphasizing the importance of repeatable processes with minimal human variability, safeguarding patient safety, preserving and tracking samples, and compliance with stringent regulatory, ethical, and quality standards.

 

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Short Biography of Presenting Author

My name is Irit Segalovich,   

I'm bringing two decades of experience in leading clinical trials and operational management in various therapeutic areas in biotechnology, medical devices and pharmaceutical industry.