To investigate the clinical feasibility of the TW22.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
tracheostomy
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The design of the study is in line with the early nature of the investigation
and is observational. There are no specific outcome measures or endpoints.
The parameters that are assessed are in line with the parameters that have been
reported in the literature to possibly be affected by the use of an HME or
Speaking Valve by tracheotomized patients (speaking, breathing, pulmonary
symptoms, swallowing, olfaction).
Secondary outcome
N.A.
Background summary
In tracheotomized patients, a tracheostomy tube is inserted in a surgically
created opening (a tracheostoma) in the neck. The main reason for this
procedure is the presence of an upper airway obstruction that is causing
difficulties breathing. Underlying medical causes are diverse and may for
example be neurological, oncological, or resulting from a trauma.
Tracheotomized patients mainly breathe through the tracheostomy tube. Depending
on the level of upper airway obstruction some air exchange may take place
through the upper airways as well. To be able to speak, a tracheotomized
patient needs to occlude the tracheostomy tube, either directly with a finger
on the opening of the tube, with a finger on a Heat and Moisture Exchanger
(HME), or without a finger using a so-called speaking valve. A bias-closed
speaking valve contains a membrane that only opens when the patient inhales; it
remains closed during exhalation which then allows redirection of the exhaled
air through the upper airways allowing speech. When breathing in through the
tracheostomy tube, the upper airways are bypassed and the inhaled air remains
unconditioned. An HME compensates for this. Exhaled air conditions the HME and
upon inhalation the HME conditions the inhaled air.
Currently, there are no devices commercially available for tracheotomized
patients that combine both functions. Technically, an HME functions when
conditioned by exhaled air. A bias-closed speaking valve redirects air through
the upper airways. Hence, when using a Speaking Valve, the exhaled air would
not pass through the HME and would not condition the HME.
This problem is overcome in the TW22. The TW22 combines a Speaking Valve with
an HME. The device can be switched from HME mode to speech mode by a simple
twisting motion, allowing the patient to benefit both from the HME function
(when in HME mode) and the Speech function (in Speech mode).
Due to the uniqueness of the device for this patient population, a clinical
feasibility study is proposed to explore the limitations and advantages of the
performance of the TW22 in 15 eligible patients.
Study objective
To investigate the clinical feasibility of the TW22.
Study design
A non-randomized, prospective, clinical investigation to evaluate the clinical
feasibility TW22 and explore its limitations and advantages.
Intervention
The use of the TW22
Study burden and risks
No new risks have been identified related to this new adhesive.
It is expected that the study may be of some burden to some patients due to the
2 required visits. The patient information and informed consent procedure will
take about 15 minutes. Each visit is expected to take about 45 minutes.
Patients that choose to stay in the study and continue use of the device will
need to visit the hospital monthly for brief follow-up and to receive a new
TW22 device.
Kraftgatan 8
SE 24222 Horby
SE
Kraftgatan 8
SE 24222 Horby
SE
Listed location countries
Age
Inclusion criteria
18 years or older;
have a tracheostomy;
sufficient cognitive ability for handling the TW22;
sufficient manual dexterity for handling the TW22;
are spontaneously breathing;
Have a tidal volume of 250 ml or more;
have a cuffless tracheostomy tube
have a tracheostomy tube with inner- and outer cannula;
have an inner tube with a 22mm connector;
are currently using an HME and/or Speaking Valve;
adequate upper airway.
Exclusion criteria
use of a too wide non fenestrated tube that does not allow air passage around the tube;
laryngectomized;
mechanically ventilated;
severe airway obstruction;
severe aspiration;
thick and copious secretions.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38880.042.12 |