Multicenter randomized 2x2 cross-over study for patient satisfaction and function of the ProTrach DualCare

Multicenter randomized 2x2 cross-over study for patient satisfaction and function of the ProTrach DualCare - Multicenter study for patient satisfaction of the ProTrach DualCare

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40675

Enrollment

Registered

2014-09-29

Start date

2015-01-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

airway opening Tracheotomy

Interventions

The ProTrach DualCare.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Secondary

Measure	Time frame
Secondary parameters are quality of life (QOL), lung function, breathing resistance, swallowing, olfaction, quality of speech and compliance.	—

Primary

Measure	Time frame
The main parameter tested will be patient preference.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)