Short Term Effect of a Heat and Moisture Exchanger on Tracheal Mucociliary Clearance in Laryngectomized Individuals

Laryngectomized patients suffer from pulmonary problems due the bypass of the
upper airway tract. This new breathing situation leads to loss of optimal
conditioning (moistening and warming) of the breathing air. Improvements of the
reduced air-conditioning after total laryngectomy can be achieved by
application of a Heat and Moisture Exchanger (HME). In theory it is likely that
an HME not only improves tracheal climate, but also positively influences
tracheal mucociliary clearance. Restored tracheal mucociliary clearance could
be responsible for further reduction of the respiratory problems. However, the
hypothetical short term HME effect on mucociliary clearance has never been
studied in laryngectomized patients. The first step is to determine whether the
short-term effect of the use of an HME on tracheal mucociliairy clearance is
measurable and significant.

Primary: Assessment of the short-term effect of a Heat and Moisture Exchanger
on tracheal mucociliary clearance in laryngectomized individuals. Secondary:
The relationship between clinical assessment, ciliary activity and mucociliary
clearance.

Tracheal mucus transport measurements are performed using scintigraphy. A
droplet of radio labelled 99mTc Nanocolloid and methylene blue is placed on
the tracheal epithelium above the carina via the permanent tracheostoma. The
displacement of radioactivity is measured using a gamma camera. First, a
baseline measurement is performed to select patients with initial mucus
transport velocity of at least 1 mm/min for statistical calculations. After a
three-week period, the baseline measurement is followed by a randomized second
and a third measurement (with and without HME). The control measurement is
performed after continuously breathing with HME. Measuring without HME is
performed after exposure of one hour breathing without HME. Tracheal brush
biopsy is performed after the first and last measurement for ciliary activity
assessment. A study specific questionnaire will be obtained at the first visit.
Frequency of coughing and mucus expectoration will be assessed using tally
sheets before and after every measurement.

Removal of HME during one hour prior to the measurement.

The subjects will experience no pain and very little discomfort from the
measurements. The intervention and measurement do not affect the respiratory
functioning. The amount of radioactivity is minimal and will not be absorbed by
the body, but will be cleared through the tracheostoma within one day.