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The Feasibility of Using Mouthpiece Ventilation Post Extubation for Acute Tetraplegia in the Intensive Care Unit.

The Feasibility of Using Mouthpiece Ventilation Post Extubation for Acute Tetraplegia in the Intensive Care Unit.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000949381
Enrollment
14
Registered
2017-07-03
Start date
2017-05-05
Completion date
2018-06-30
Last updated
2019-01-28

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

Conditions

None listed

Brief summary

Aim: To explore the feasibility of mouthpiece ventilation (MPV) use in the intensive care environment for patients who are extubated after suffering a cervical spinal cord injury and the barriers and enablers from a practice perspective. Significance: Respiratory failure and the need for re-intubation for those suffering acute tetraplegia is a known risk which extends ICU stay and costs, delays rehabilitation and increases stress for patients and their families. This is the first time that early application of MPV combined with standard conventional treatment in patients with cervical spinal cord injury (SCI) has been evaluated. This team will lead the way by taking the first steps towards determining if MPV can be utilised to deliver post extubation breathing support. The findings from this study will form the foundations to determining if MPV can impact on outcomes such at extubation success, need for re-intubation and ICU length of stay (LOS). Outcomes: This study will provide much needed pilot data about a MPV intervention for catastrophic injury populations. More importantly, this study will inform of relevant factors that will likely lead to effective translation of this intervention into routine clinical practice, including the resources and education. Data from this pilot study will inform a larger study to determine the effectiveness of MPV and the health and economic benefits for individuals and the health care system. The internal and external connections established with the clinical advisory group during this study will support collaboration for a larger future trial.

Interventions

Participants will utilise a portable ventilator (Philips Trilogy 100) that delivers mouth piece ventilation (MPV) to support their inspiratory effort once extubated. This device provides inspiratory support via a mouthpiece or straw when participant is awake and alert and wishing to expand their lungs. The device will be set up and intervention carried out with a Senior Physiotherapist with greater than 10 years experience. All patients admitted with cervical spinal cord injury, requiring intub

Participants will utilise a portable ventilator (Philips Trilogy 100) that delivers mouth piece ventilation (MPV) to support their inspiratory effort once extubated. This device provides inspiratory support via a mouthpiece or straw when participant is awake and alert and wishing to expand their lungs. The device will be set up and intervention carried out with a Senior Physiotherapist with greater than 10 years experience. All patients admitted with cervical spinal cord injury, requiring intubation and being cared for in ICU will be approached for inclusion. This feasibility study will only be conducted at Princess Alexandra Hospital, Brisbane. Participants will utilise this MPV device prophylactically from the time they are extubated through to when the participant is either discharged from ICU, requires re-intubation or dies. The participant will determine how much they utilise the MPV device to relieve any breathlessness, assist with clearing airway secretions or relieving mild fatigue. The amount of time they utilise the device will be recorded on a data memory card within the device.

Sponsors

Princess Alexandra Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

All patients with newly diagnosed tetraplegia (spinal cord injury of the neck) requiring intubation and mechanical ventilation consecutively admitted to the ICU of the PAH over a 12month period will be included.

Exclusion criteria

Potential patient participants will not be included if they are pregnant or under the age of 18

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026