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Completed
NCT05604079
Electrolarynx for Enabling Communication in the CHrOnically Critically Ill (EECCHO)
Conditions: Communication
Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 24
Sponsor: Michael Garron Hospital
Location: Canada
Summary
All critically ill patients receiving mechanical ventilation experience a period of inability to speak due to the need for cuffed endotracheal or tracheostomy tubes.
Consequences of the inability to speak include: significant emotional distress; unrecognized pain; sleeplessness; increased use of restraints, self-extubation and line removal, as well as injury to self and healthcare professionals.
Communication methods such as word mouthing, gesticulating, and writing may be ineffective and result in frustration.
Recent technological innovations include communication boards and electronic speech generating devices however these require fine motor skills and coordination which may not be intact in the chronically critically ill.
The Electrolarynx was recently shown to be effective in establishing communication in a case study of an intubated patient.
Despite the well-recognized deleterious consequences of speech incapacity, few studies have evaluated communication strategies in the critically ill and no published study has evaluated the Electrolarynx in this patient population.In this study, the investigators aim to assess the feasibility and patient acceptability of establishing speech with an Electrolarynx for intubated or tracheostomized patients experiencing difficult weaning and unable to tolerate cuff deflation.
Feasibility will be determined by the proportion of participants able to produce intelligible and comprehensible speech.
The investigators will also collect data on consent rates, reasons for refusal, the proportion of eligible patients and the time required for research procedures to inform future studies.
The investigators will provide participants with a maximum of five Electrolarynx training sessions.
On completion the investigators will measure speech intelligibility, comprehensibility, and patient acceptability using the Assessment of Intelligibility of Dysarthric Speech and the Ease of Communication scale.
Satisfaction with communication and anxiety will be measured before and after Electrolarynx training.
To the investigators' knowledge, this study will be the first to rigorously evaluate, using previously validated measures, the feasibility of the Electrolarynx for establishing communication for mechanically ventilated patients.
Eligibility Criteria
Inclusion Criteria:endotracheal tube or tracheostomy in situ and unable to tolerate cuff deflation for > one houralert, awake and able to follow simple commands demonstrated by a Glasgow Coma Score of 15 with the verbal score assigned for the ability to communicate words using non-vocal methodsable to read and understand English≥ 18 years oldunimpaired oral-motor capabilities (functional speech structures) assessed by standard oral-peripheral examination by a speech language pathologist and capable of mouthing words in response to orientation questionsmeets all the above criteria and is anticipated to require mechanical ventilation for a further 5 daysconsent to participate..Exclusion Criteria:pre-existing hearing or speech impairment that seriously interferes with communication before hospitalization (as documented in chart or reported by family members)previous diagnosis of dementia identified in the patient's medical history.
Source: ClinicalTrials.gov (NCT05604079). StuddyBuddy aggregates publicly available trial information.