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.