A new medical device to assist the introduction of ambulatory 24-h pH-metry probe.

摘要

Oesophageal manometry (OM) and ambulatory 24-h oesophageal pH-metry (OP) are the techniques for clinical investigation of gastro-oesophageal reflux disease (GORD) . These procedures require nasal intubation, and are generally not tolerated by patients . The optimal catheter should be small enough in diameter, flexible and biocompatibleso that intubation is easily performed and that the catheter is comfortable for the patient during the study. We evaluated introduction-time (IT) and patient satisfaction (PS) during the introduction of the pH-probe after OM with a new medical device, a polyethylene mini-overtube (MOT), length of 30 cm, bent with a cord of 20 cm, with an inner diameter of 13 Fr and an outer diameter of 14.5 Fr. One hundred patients were enrolled and randomised into two groups: the control group performed with the typical intubation method (50 patients; 27 females and 23 males; mean age 52.6 +- 15.7 years) and the MOT group performed with the mini-overtube (50 patients; 29 females and 21 males; mean age 53.8 +- 15.6 years). OMs were performed using a six lumen, water-perfused OM catheter made of PVC and with a maximum diameter of 4 mm (12 Fr) (BioengineeringLaboratories s.p.a.; Cantu, CO); 24-h OP-monitoring was performed using a glass electrode (diameter of 1.5 mm) connected to a portable digital memory unit (LoT 142; MettlerToledo, M.I.C., Champagne au Mont D'Or; France). Before the OM study, MOT was placed on the manometric probe at its distal extremity. Firstly to extract manometric probe, the MOT was advanced on to overtake, for some centimetres, the upper oesophageal sphincter (UOS). When the OM-probe was extracted, the OP-probe was inserted using the MOT as a guide.