Criterion validity study of the Vent-Pipe adapter in baseline forced spirometry in laryngectomized patients

To determine the criterion validity of the Vent-Pipe adapter for performing baseline forced spirometry in laryngectomized patients, in comparison with a standard device.

A cross-sectional study was conducted between 2019 and 2020 in the pulmonary function testing laboratory at the Hospital General Universitario Reina Sofía, Region of Murcia, Spain. Baseline forced spirometry tests were performed on each patient using both the standard device and the new Vent-Pipe prototype, which was created with biocompatible material using 3D printing. Paired sample Student's t-tests were used to compare mean differences in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). Intraclass correlation coefficients (ICC) and their 95% confidence intervals were also calculated.

52 laryngectomized patients (86.5% male, mean age 65.7 years) were analyzed. The Vent-Pipe prototype showed statistically significant differences (p < 0.0001) compared to the standard device in FVC (-0.62 l/s) and FEV1 (-0.37 l/s), as well as in percentage values, with differences of -15.09% for FVC and -14.25% for FEV1. ICCs indicated low agreement for FVC% (ICC = 0.488, 95% CI: 0.180 to 0.714) and moderate agreement for FEV1% (ICC = 0.705, 95% CI: 0.045 to 0.889).

The Vent-Pipe prototype significantly improves pulmonary function measurements in laryngectomized patients compared to previous standard devices. Its main advantage, combined with the adhesive plate, lies in its ability to adapt to each patient's tracheostoma, minimizing air leakage.