Long Term Effects of Heat and Moisture Exchangers (HMEs)

Atos Medical

Status: Enrolling

Conditions: Laryngectomy; Status

Treatments: Device: Provox Life

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06084611

PL_Brazil

Details and patient eligibility

About

Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total laryngectomy, irrespective of pharynx reconstruction method
• 18 years or older
• Longer than 3 months after total laryngectomy
• Longer than 6 weeks after postoperative radiotherapy

Exclusion criteria

• Current use of HMEs (within last 3 months)
• Medical problems prohibiting the use of HME
• Active recurrent or metastatic disease (medical deterioration)
• Recent pulmonary infections/unstable pulmonary condition
• Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
• Low tidal volumes
• Unable to understand the Participant Information and/or unable to give Informed Consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Provox Life HME

Experimental group

Description:

Use of Provox Life HMEs and attachment

Treatment:

Device: Provox Life

Control - No HME

No Intervention group

Description:

Control group is current standard of Care in Brazil, which is not using an HME