Methods
Ethical Considerations:
The institutional ethics committee approved the protocol for the study, and we obtained clearance to conduct a prospective study.
Study Design and Patients
This prospective case-control study was done to objectively analyze the degree of nasal mucociliary impairment in 30 patients with prolonged tracheostomy when compared with that in age and sex matched 30 healthy individuals. This study was conducted in the Department of Otorhinolaryngology in a tertiary care center for a period of 2 years after obtaining clearance from the institutional ethics committee. The patients who were between the age of 20-60 years with no history of pre-existing ciliary disorders or naso-sinus pathology and who were tracheostomized for at least 4 weeks were recruited as cases. Similarly, healthy volunteers aged between 20-60 years with no known naso-sinus pathology were recruited as controls.
All subjects enrolled underwent the Saccharin test after taking an informed written consent in which a standardized 1mm saccharin pellet was kept on the anterior end of inferior turbinate of one side under direct visualization with a nasal endoscope in supine position. Patients remained in the same position and were told to report as soon as they appreciated sweet taste in their throat. During the test the subjects were asked to quietly inhale and exhale and not to sniff, sneeze, eat, drink or swallow frequently. Time taken for the perception of sweet sensation in the throat was measured as saccharin transit time (STT).
All the parameters were then entered in a master chart, and statistical analysis of data was done using Microsoft Excel 2019 software. The Categorical variable was summarized by frequency and percentile, whereas the continuous variable was summarized by the mean and standard deviation. ‘Independent sample t-test’ was used to compare the meantime across two groups. The primary outcome of the study was measured as the alteration in nasal mucociliary clearance time by the saccharin test.