A prospective study to assess the safety and efficacy of Heat and Moisture Exchange filters and humidifiers in Mechanically Ventilated Patients.

Title of the Study: A prospective study to assess the safety and efficacy of Heat and Moisture Exchange filters and humidifiers in Mechanically Ventilated Patients.

Primary Objective:

To evaluate the efficacy of HME filters in maintaining airway humidity.

Secondary Objective:

To assess the safety of HME filters by monitoring device-related adverse events.

To measure changes in ventilatory parameters and respiratory mechanics.

Duration of the study:

a. The total duration of the study:

3 months

b. Time taken for each subject (if it involves interviews, follow up period):

There is no follow-up involved in this study

Sample Size:

sample size of 90 for this study is determined based on statistical considerations to ensure adequate power for detecting clinically significant differences in the safety and efficacy outcomes of Heat and Moisture Exchange (HME) filters and active humidifiers in mechanically ventilated patients.

Results of study-

The clinical study of all tested variants, including EMD-HVF-S, EMD-HVF-B, EMD-HS-1, EMD-HS-2, EMD-HCH04, and EMD-HCHV6, demonstrated consistent and reliable performance in maintaining tracheal humidity, temperature, and airway pressure across 15 patients per variant, totaling 90 patients. All variants effectively ensured optimal humidification, filtration, and secretion barriers, maintaining stable and safe conditions throughout the study period.

The overall product experience, evaluated by the Principal Investigator (PI), reflected high satisfaction, with most ratings categorized as Excellent and Very Good. No risks, side effects, or adverse events were observed during the study, further supporting the safety, effectiveness, and clinical benefits of the evaluated product variants. These findings confirm that the devices met clinical expectations and delivered consistent, reliable performance

conclusion-

The clinical evaluation of six device variants: EMD-HVF-S, EMD-HVF-B, EMD-HS-1, EMD-HS-2, EMD-HCH04, and EMD-HCHV6, across a total of 90 patients (15 per variant), demonstrated consistently favorable outcomes in alignment with the predefined study endpoints.

The primary endpoint, measurement of airway humidity using digital psychrometry, confirmed that all variants successfully maintained optimal tracheal humidity and temperature levels throughout the 24-hour observation period. This highlights the effectiveness of the devices in delivering consistent humidification, which is critical for patient safety during mechanical ventilation.

Regarding the secondary endpoints:

Ventilatory parameters, including peak airway pressures, remained stable across all variants, with only minor, clinically acceptable fluctuations observed, indicating effective ventilatory performance.

No device-related adverse events were reported, underscoring the safety profile of each product.

No cases of ventilator-associated pneumonia (VAP) were observed during the study, suggesting that the devices provided an effective barrier against infection.

Additionally, performance feedback collected from the PI using a five-point Likert scale indicated high satisfaction across key parameters, including filtration efficiency, humidification, secretion barrier function, and ease of use. The majority of ratings were categorized as Excellent, with no instances of poor performance.

In summary, the study confirms that all tested variants are safe, effective, and clinically reliable, meeting the intended performance criteria and supporting their continued use in ventilated patients.