Electrolarynx for Enabling Communication in the CHrOnically Critically Ill (EECCHO)

NCT05604079 | Completed

• 1 other identifier: TorontoEGH
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Communication

Keywords

communication; mechanical ventilation; weaning

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Electrolarynx for establishing successful communication defined as the ability to generate speech that is intelligible and comprehensible

  We determined speech intelligibility and comprehensibility using the Assessment of Intelligibility of Dysarthric Speech (AIDS), a validated objective tool for quantifying single-word and sentence intelligibility. Intelligible speech was arbitrarily defined as ≥70% of words identified correctly by raters. Ability to establish comprehensible speech was defined as a difficulty score of ≤ 5 averaged over the five sentences.

  Within 5 days of training

Secondary Outcomes (6)

• Perceived ease and satisfaction with use

  Within 5 days of training

• Training time

  Commencement and completion of training - training is a maximum of five days

• Anxiety

  Within 5 days of training

• Consent rate

  One month after completion of study recruitment

• Time to complete research measures

  One month after completion of study recruitment

Study Arms (1)

Electrolarynx

EXPERIMENTAL

In this single arm study, all participants will receive training in the Electrolarynx

Device: Electrolarynx

Interventions

Electrolarynx DEVICE

The device transmits electronic sound source vibrations through soft tissue, either the neck at the level of the glottis, or less commonly the check. Speech is created through movements of articulators including the lips, tongue and jaw.

Electrolarynx

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• endotracheal tube or tracheostomy in situ and unable to tolerate cuff deflation for \> one hour
• alert, 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 methods
• able to read and understand English
• ≥ 18 years old
• unimpaired 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 questions
• meets all the above criteria and is anticipated to require mechanical ventilation for a further 5 days
• consent to participate..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Garron Hospital: lead
• Sunnybrook Health Sciences Centre: collaborator
• Unity Health Toronto: collaborator

Study Sites (3)

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Care Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: November 3, 2022
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 3, 2022

Record last verified: 2021-05

Locations

CA (3)