Short-term clinical feasibility of a new Speaking Valve with a heat- and moisture exchanger (TW22) for tracheotomized patients.

Short-term clinical feasibility of a new Speaking Valve with a heat- and moisture exchanger (TW22) for tracheotomized patients. - Clinical feasibility of the TW22

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37865

Enrollment

Registered

2012-05-14

Start date

2012-06-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tracheostomy airway opening tracheotomy

Interventions

The use of the TW22

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)