None listed
Conditions
Brief 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.
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 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 f
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
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Tracheostomy inserted in ICU – air filled cuffed tube Mechanically ventilated but able to spontaneously breathe Able to obey one stage commands within the previous 24 hrs Tracheostomy leak demonstrated on cuff deflation to be >40% of tidal volumes >18 years of age Within 72 hrs of tracheostomy Expected stay in ICU beyond next calendar day
Exclusion criteria
Deemed unsuitable for speaking valve by primary physician – reason to be recorded Requiring heavy sedation for high intracranial pressures PEEP required >10 FiO2 required >60% Severe airway obstruction which may prevent sufficient exhalation Severely reduced lung elasticity which may cause air trapping
Outcome results
None listed