In this research we want to determine whether patients prefer the ProTrach DualCare over other speaking valves, if it improves quality of life, compliance with HME use and lung function.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter tested will be patient preference.
Secondary outcome
Secondary parameters are quality of life (QOL), lung function, breathing
resistance, swallowing, olfaction, quality of speech and compliance.
Background summary
Tracheotomized patients lack the function of the upper airway: moisturizing,
warming and filtering the air. Heat and Moisture Exchangers (HME) are developed
to regain some of the upper airway functions: moisturizing, filtering larger
particles, and heating the air. An HME works by retaining the heat and moisture
of exhaled air passing through it. This is associated with better lung function
and less secretions.
Furthermore tracheotomized patients are unable to speak as the air is not
passed through the vocal cords. The loss of speech is resolved by patients
closing their tracheostomy tube with a finger or by a speaking valve
redirecting the air through the upper airway. A speaking valve contains a
membrane that is closed when patients exhale. Advantages of a speaking valve
are hands free use, reduction of aspiration by maintaining subglottic pressure,
better olfaction and less damage of trachea and skin.
Until now one had to choose between a speaking valve and an HME. With the
ProTrach DualCare (Atos Medical, Hörby, Sweden) a speaking valve and functional
HME are combined in one device, using a *speaking* and an *HME* mode. This is
expected to improve lung function, and quality of life (QOL) of tracheotomized
patients depending on their original device.
Study objective
In this research we want to determine whether patients prefer the ProTrach
DualCare over other speaking valves, if it improves quality of life, compliance
with HME use and lung function.
Study design
The study is a multicenter randomized 2x2 cross-over design. Allocation of the
patients to the two treatment orders will be randomized within center, but the
study is not blinded as the patient and the investigator will know that the
ProTrach DualCare is used.
Intervention
The ProTrach DualCare.
Study burden and risks
Risks using the ProTrach DualCare include higher breathing resistance in
speaking mode, clogging of the ProTrach DualCare HME with coughed up phlegm and
increased mucus production in the first days of use due to the HME effect.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
18 years or older;
have a tracheostomy;
sufficient cognitive ability for handling the ProTrach DualCare;
sufficient manual dexterity for handling the ProTrach DualCare;
are capable of using a speaking valve;
adequate upper airway
Exclusion criteria
use of a tube that does not allow air passage around the tube;
laryngectomized;
mechanically ventilated 24/7;
cannot tolerate added dead space or breathing resistance from study devices;
severe airway obstruction;
severe aspiration;
thick and copious secretions;
unable to understand the Patient Information and/or unable to give Informed Consent;
patient does not have a 15mm or 22mm connector
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 | NL49286.042.14 |