Primary objective is to measure the effect of the use of different HMEs with different fluid exchange, and the effects of changing between HME routines, on the tracheal mucociliary transport in laryngectomered individuals.Secondary objectives are to…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scintgraphy acquisition from which the tracheal mucus transport velocity will
be calculated
Secondary outcome
Tally sheets
CASA-Q
Background summary
The aim of the research is to gain more insight into the physiological effects
of HME-routines with different fluid exchange, and the effects of changing
between HME routines, on the tracheal climate after total laryngectomy. It is
hypothesized that there is a positive relationship between the fluid exchange
of an HME and the mucociliary transport in laryngectomees. This study could
provide a basis for new developments in HMEs to further reduce airway problems
in laryngectomized people.
Study objective
Primary objective is to measure the effect of the use of different HMEs with
different fluid exchange, and the effects of changing between HME routines, on
the tracheal mucociliary transport in laryngectomered individuals.
Secondary objectives are to investigate the relationship between the tracheal
mucociliary transport, the clinical data on (experienced) lung complaints and
HME type and to develop a gold standard to test the HME effect on mucociliary
clearance.
Study design
To investigate the effect of HME use of different HME types with different
fluid exchange on the tracheal climate in vivo, 20 total laryngectomees will be
asked to use three different types of HMEs (1 control HME and 2 intervention
HMEs with different fluid exchange activity), each during two weeks, in
combination their normal daily routine for confirming these HMEs. For this
study, the participants have to come to the hospital three times (duration per
visit: 1.5 hours). During the first visit, a tally sheet and CASA-Q
questionnaire is filled out (about experienced lung complaints) and a baseline
scintigraphy acquisition is made. Thereafter, the participant will return for a
scintigraphy acquisition two more times, each after a period of two weeks in
which they use a different type of intervention HME. Based on this scintigraphy
acquisition, the mucociliary transport of mucus can be determined, thus
quantifying the effect of the different HME types on the tracheal climate.
In addition to the scintigraphy acquisitions, as a clinical outcome measure,
participants will be asked to record the frequency of coughing and coughing up
phlegm on a tally sheet and CASA-Q after each two-week period for 48 hours.
Intervention
Three different types of HMEs can be used (1 control HME and 2 intervention
HMEs with different moisture exchange effect)
Study burden and risks
Participants may experience more mucus / coughing through the use of the HME
intervention
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Laryngectomized patient
- 18 years or older
- Daily HME user
- At least 6 months post-surgery
- Stable pulmonary condition
- Be proficient in Dutch
- Signed informed consent
Exclusion criteria
- Medical problems prohibiting the use of HME
- Active recurrent or metastatic disease or lung cancer
- Clinical signs of pulmonary or tracheal infection less than 6 weeks prior to
study participation
- Inability of lying still in supine position during 45 minutes
- Use of short-acting bronchodilators less than six hours prior to study
- Use of long*acting bronchodilators less than twenty four hours prior to the
study
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL76014.031.20 |