The Purpose of the study is to investigate the clinical feasibility of the TW15 and TW22.
ID
Source
Brief title
Condition
- Other condition
- Upper respiratory tract disorders (excl infections)
Synonym
Health condition
tracheostomy
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exploratory - none. Exploratory parameters are: lungfunction (cough, mucus),
breathing, aspiration, speaking, olfaction, use, maintenance and overall
statisfaction of the patients.
Secondary outcome
N.A.
Background summary
Title
Phase 2 clinical feasibility study of a new Speaking Valve with a heat- and
moisture exchanger (TW) for tracheotomized patients.
Background and Rationale
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 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 hands free using a so-called speaking valve. A 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 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.
Technically, an HME functions when exhaled air passes the HME and conditions
the HME media. A bias-closed speaking valve (i.e. a Speaking Valve that only
opens upon inhalation) redirects air through the upper airways. Hence, when
using a bias-closed Speaking Valve, the exhaled air would not pass through the
HME and would not condition the HME. Currently, there are no devices
commercially available for tracheostomy patients that combine both functions.
The TW, however, combines a bias-closed Speaking Valve with an HME. The device
can be switched from HME mode to speaking mode by a simple twisting motion,
allowing the patient to benefit both from the HME function (when in HME mode)
and the Speaking function (in Speaking mode).
Due to the uniqueness of the device for this patient population, a clinical
feasibility study has been conducted at the UMCG to explore the limitations and
advantages of the performance of the TW Speaking Valve used in combination with
a TW22 HME cassette in 14 patients. The outcomes of this early feasibility
study were generally positive, and have led to some design changes to the TW
Speaking Valve. The current study aims to investigate the redesigned TW
Speaking Valve, now in combination with both a 15 mm and a 22 mm HME cassette,
to allow use with tracheostomy tubes with a 15 mm and a 22 mm connector.
Study objective
The Purpose of the study is to investigate the clinical feasibility of the TW15
and TW22.
Study design
The investigation will be a non-randomized, prospective study in which the
patient will act as his own control. All patients are intended to use the TW
device for two weeks: one week with the 15 mm HME cassette and one week with
the 22 mm HME cassette. After two weeks, if the patient wishes to do so, the
patient can continue to use the TW device with the HME cassette of their
choice. The study will take a maximum of three months.
Intervention
The use of the TW device for a period of 2 weeks, with the option to continue
using it until 3 months. After these three months, patients can continue to use
the device for a total of one year if the device is not yet commercially
available.
Study burden and risks
No new risks have been identified related to the new TW device.
It is expected that the study may be of some burden to some patients due to the
required visit to the hospital and the meetings on the telephone. The patient
information and informed consent procedure will take about 15 minutes. Each
contact moment is expected to take about 45 minutes. Patients that wish to
continue using the device after two weeks will have a contact moment every four
weeks until week 14 to record any adverse events/adverse device effects and
changes in medication. At week 14 the patient will be asked to complete
structured questionnaires. If the patient continues using the device after week
14, there will be a monthly follow-up to record any adverse events/device
effects and changes in medication.
Kraftgatan 8
Horby SE 24222
SE
Kraftgatan 8
Horby SE 24222
SE
Listed location countries
Age
Inclusion criteria
• is 18 years or older;
• has a tracheostomy;
• is spontaneously breathing;
• has a cuffless tracheostomy tube;
• has a tracheostomy tube with inner- and outer cannula;
• currently uses an HME and/or speaking valve.
Exclusion criteria
• is unable to handle or remove the device him/herself when needed, e.g. has decreased level of cognition or reduced mobility of the arms and/or hands;
• is mechanically ventilated in any way;
• has a tidal volume of less than100 ml;
• is suffering from severe aspiration;
• is laryngectomized; the device will block the possibility to exhale if speaking mode is unintentionally activated;
• has severe upper airway obstruction, this may cause air trapping;
• has thick and copious secretions, which might block the device.
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 | NL43634.042.13 |