A randomised controlled trial of early versus standard Speech Pathology review and intervention: tracheostomy patients in intensive care

A randomised controlled trial of tracheostomy patients in intensive care receiving early versus standard Speech Pathology intervention, does this lead to improved time to verbal communication and patient reported quality of life/satisfaction?'

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000075088

Acronym

ESPRIT

Enrollment

Registered

2010-01-20

Start date

2010-03-10

Completion date

2014-10-31

Last updated

2020-01-13

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 purpose of the study is to examine if access and provision of early Speech Pathology intervention for ventilated tracheostomy patients in intensive care improves their time to communicate verbally, increases their quality of life and satisfaction and is safe.

Interventions

Speech Pathology intervention, tracheostomy cuff deflation on ventilation, use of speaking valve. This is early Speech Pathology intervention which involves cuff deflation during mechanical ventilation (limit positive end expiratory pressure (PEEP) >=10) and insertion of a Passy Muir Speaking valve into the venitaltion circuit. The valve will be used for up to 1 hour day 1; 2 hours day 2; day 3 up to 4 hours and day 4 onwards up to 8 hours.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Air filled cuffed tracheostomy tube Mechanically ventilated with Postive end expiratory pressure (PEEP) </= 10, Fraction of inspired oxygen (FiO2) </= 0.4 Tracheostomy formed for minimum 48 hours Spontaneously triggering ventilator Able to obey commands Clincally stable (respiratory rate between 8-24 breaths per minute, oxygen saturation >88% of peripheral oxygen saturation(SpO2), heart rate between 40-120 beats/min and systolic blood pressure between 90-160mmHg)

Exclusion criteria

Contra indication to cuff deflation as per treating intensivist (eg bulbar palsy, brainstem cerebral vascular accident (CVA) Recent Head and neck surgery

Outcome results