Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Loewenstein Hospital

Status: Enrolling

Conditions: Tracheostomy

Treatments: Other: control; Device: Shiley™ phonate speaking valve

Study type: Interventional

Funder types: Other

Identifiers

NCT05482022

0027-21-LOE

Details and patient eligibility

About

Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.

The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• brain injury (traumatic/non-traumatic).
• tracheostomy.
• unresponsive wakefulness syndrome or minimally conscious state.
• fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.
• the legal guardian speaks Hebrew.

Exclusion criteria

• airway stenosis / inflammation.
• oxygen saturation <90%.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

speaking valve

Experimental group

Description:

Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).

Treatment:

Device: Shiley™ phonate speaking valve

control

Other group

Description:

Respiratory physical therapy treatments conducted without using a speaking valve .

Treatment:

Other: control