RecruitingACTRN12624000952549

Effect of Early use of in-line speaking valve on time to wean from mechanical ventilation in Intensive Care Unit patients with tracheostomies: a pilot randomised controlled trial


Sponsor

Sir Charles Gairdner Hospital

Enrollment

40 participants

Start Date

Apr 4, 2024

Study Type

Interventional

Conditions

Summary

In patients who are unable to be safely taken off a mechanical ventilator a tracheostomy is often placed to help protect their airway gradually reduce the mechanical ventilator support. One-way valves can be used within a ventilator circuit to direct air through the upper airway during expiration, allowing speech and communication.  Research suggests the use of speaking valves during mechanical ventilation is safe, improves communication, may reduce time to weaning off ventilation and removal of tracheostomy. This project aims to evaluate whether the early use of a speaking valve within the ventilator circuit in suitable patients results in earlier weaning from mechanical ventilation and earlier communication.   The primary outcome will be feasibility and safety with the ability to pivot to a primary outcome of duration of mechanical ventilation post tracheostomy utilising the pilot results.  Secondary outcomes include mechanical ventilation duration, ease of communication, patient and family, satisfaction and length of stay.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Patients in intensive care who need long-term help breathing may have a tracheostomy — a small opening in the throat to support ventilation. Weaning patients off the mechanical ventilator is an important goal, but it takes time. Speaking valves are small one-way devices that can be fitted into the ventilator circuit to allow air to flow through the upper airway during breathing out, enabling the patient to speak. Some research suggests these valves may also help patients wean off the ventilator faster. This pilot study is testing whether introducing a speaking valve early — within 72 hours of a tracheostomy — is safe and leads to shorter time on the ventilator and better communication compared to standard care. The primary aim is to establish whether a larger definitive trial is feasible and safe. You may be eligible if you are 18 or older, are a patient in an ICU with a tracheostomy in place, are mechanically ventilated but able to breathe spontaneously, can follow simple commands, and are expected to remain in the ICU for at least another day. Patients who need heavy sedation, very high ventilator settings, or who have severe airway obstruction are not eligible. The study is run at Sir Charles Gairdner Hospital.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Early use of speaking valve in patients who have received tracheostomy in intensive care units (within 72 hours of tracheostomy insertion) 1.Insertion of standard one way speaking valve into ventilat

Early use of speaking valve in patients who have received tracheostomy in intensive care units (within 72 hours of tracheostomy insertion) 1.Insertion of standard one way speaking valve into ventilator circuit (speaking valve is put into ventilator circuit for the period of the intervention) 2. Initial application will be performed by speech pathologist and physiotherapist and within 72 hours of tracheostomy. Subsequent applications may be done by suitably trained nursing staff 3. Aim will be for 30-60 minutes initially once and then twice daily up to 60 minutes the following day (may be extended longer with time recorded if tolerated well by the patient). The speaking valve is removed from ventilator circuit at the end of each trial. This will continue daily until the patient is weaned from the ventilator (at which point all patients will have access to non ventilator circuit speaking valves as is standard practice) 4. Successful application, time applied/duration will be recorded and any reason for failure Ventilator strategies will be as per the treating clinician


Locations(2)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12624000952549


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