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Determining the Safety and Benefits of Exercising Patients with a Tracheostomy and a Speaking Valve

Determining the Safety and Benefits of Exercising Tracheostomised Mechanically Ventilated Patients with Passy-Muir Speaking Valves

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000148178
Enrollment
20
Registered
2019-02-01
Start date
2021-05-19
Completion date
2024-06-05
Last updated
2025-09-29

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

Conditions

None listed

Brief summary

The focus of this study is to determine the safety and benefits of exercising patients who are mechanically ventilated via a tracheostomy whilst using a Passy-Muir speaking valve. The benefits of early exercise for patients in ICU have been well documented including: decreased ICU length of stay (LOS), hospital LOS and more ventilator-free days. Furthermore for tracheostomised patients, the benefits of utilising speaking valves (SVs) include: less accumulated secretions, decreased carbon dioxide retention, decreased respiratory rate, improved lung recruitment and greater verbal communication. Unfortunately the use of SVs has been limited due to concerns of lung derecruitment during a period of cuff deflation or conversely in some patients, hyperinflation. Fortunately recent studies have addressed these safety concerns by demonstrating that SVs did not cause derecruitment or hyperinflation of the lung, rather resulted in improved lung recruitment. It is important to note that these studies were completed with patients at rest, therefore the effect on the lungs during physiotherapy or exercise still needs to be investigated.

Interventions

The exercise component will include five minutes of MOTOmed Letto cycling (administered and supervised by a trained intensive care physiotherapist), starting with a resistance of zero and increasing the resistance by one level each minute. The MOTOmed® Letto is a lower limb cycle ergometer that allows the lower limbs to be trained passively, motor-assisted and actively. The patient can exercise either lying in bed or sitting in a chair. The exercise will cease at five minutes or if any serious a

The exercise component will include five minutes of MOTOmed Letto cycling (administered and supervised by a trained intensive care physiotherapist), starting with a resistance of zero and increasing the resistance by one level each minute. The MOTOmed® Letto is a lower limb cycle ergometer that allows the lower limbs to be trained passively, motor-assisted and actively. The patient can exercise either lying in bed or sitting in a chair. The exercise will cease at five minutes or if any serious adverse events occur.

Sponsors

Physiotherapy Department - The Prince Charles Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adult patients admitted to ICU with a tracheostomy. • Adult patients admitted to a hospital ward or discharged to a ward from ICU with a tracheostomy.

Exclusion criteria

• Age under 18 • Patients unable or unwilling to provide informed consent • Injuries to lower limbs preventing them from being able to participate in exercise therapy • Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs and/or has lower limb movement restrictions preventing them from being able to do cycle ergometry • Cardiovascular instability as determined clinically by the treating therapist or medical staff • Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury) • Death is deemed imminent and inevitable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026