JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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[A design and study of a novel electronic device for cuff-pressure monitoring].

OBJECTIVE: To design a novel electronic device for measuring the pressure in the cuff of the artificial airway; and to study the advantage of this device on continuous and intermittent cuff pressure monitoring.

METHODS: (1) a portable electronic device for cuff pressure measurement was invented, which could turn pressure signal into electrical signal through a pressure transducer. Meantime, it was possible to avoid pressure leak from the joint and the inside of the apparatus by modified Luer taper and sophisticated design. If the cuff pressure was out of the normal range, the apparatus could release a sound and light alarm. (2) Six traditional mechanical manometers were used to determine the cuff pressure in 6 tracheal tubes. The cuff pressure was maintain at 30 cmH2 O (1 cmH2 O = 0.098 kPa) by the manometer first, and repeated every 30 seconds for 4 times. (3) Study of continuous cuff pressure monitoring: We used a random number generator to randomize 6 tracheal tubes, 6 mechanical manometers and 6 our products by number 1-6, which has the same number of a group. Every group was further randomized into two balanced groups, one group used the mechanical manometer first, and the other used our product first. The baseline pressure was 30 cmH2 O, measurement was performed every 4 hours for 6 times.

RESULTS: When traditional mechanical manometer was used for cuff pressure monitoring, cuff pressure was decreased by an average of 2.9 cmH2 O for each measurement (F = 728.2, P = 0.000). In study of continually monitoring, at each monitoring point, the pressure measured by electronic manometer was higher than the mechanical manometer. All the pressures measured by mechanical manometer were dropped below 20 cmH2 O at 8th hour, and there was no pressure decrease below 20 cmH2 O measured by electronic manometer in 24 hours by contrast. In study of intermittent monitoring, the same result was found. The pressure was dropped significantly with time when measured by mechanical manometer (F = 61.795, P = 0.000), the drops below 20 cmH2 O began at 8th hour; but when measured by electronic manometer, all the value stayed unchanged around the baseline in 24 hours (F = 0.511, P = 0.796).

CONCLUSIONS: Compared with traditional mechanical manometer, cuff pressures monitored by our novel electronic manometer were steadier in both continuous and intermittent monitoring. The device is compact and convenient, and can provide a good solution for continuously monitor of the tracheal cuff pressure.

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