Validation of a novel syringe based monitor (AG CUFFILL) for measurement of endotracheal tube cuff pressure in adult patients

• Author Details:   
• Sowmya Kasa
• Madhavi Singh
• Siddharth Rampally
• Polineni Sahithi Chowdary
• R.S. Sachidanand1
• Aishwarya Mantri ^*
• Shubham Jaju

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Background: Accurate measurement of endotracheal tube (ETT) cuff pressure is essential to prevent complications from under- or over-inflation. Conventional aneroid manometers are considered the gold standard but are limited by cost, bulk, and availability. The AG CUFFILL is a novel syringe-based device that allows simultaneous cuff inflation and digital pressure display. This study aimed to validate AG CUFFILL against the standard aneroid manometer in adult patients.

Materials and Methods: This prospective observational study included 85 adult patients undergoing elective surgery under general anesthesia with cuffed ETTs. After intubation, cuff pressure was measured sequentially with an aneroid manometer and AG CUFFILL using a three-way stopcock. Demographic and clinical data were recorded. Agreement between devices was analysed using paired t-test, Pearson correlation, and Bland–Altman analysis. A p-value <0.05 was considered statistically significant.

Results: The mean cuff pressure measured by AG CUFFILL (37.43 ± 13.38 cm H₂O) was comparable to that measured by the aneroid manometer (37.08 ± 13.05 cm H₂O), with no statistically significant difference (p = 0.254). A very strong positive correlation was observed between devices (r = 0.979, p < 0.001). Bland–Altman analysis showed minimal bias (–0.35 cm H₂O) and most measurements lay within limits of agreement, confirming good concordance.

Conclusion: AG CUFFILL demonstrated excellent agreement with the aneroid manometer for ETT cuff pressure measurement and represents a reliable, portable, and user-friendly alternative for routine clinical use, particularly in resource-limited or high-volume settings.