Electrolarynx for Enabling Communication in the CHrOnically Critically Ill (EECCHO)
Condition: Communication
Study type: Interventional

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.
    

Detailed description: 
      Despite the well-recognized deleterious consequences of speech incapacity, few studies have
      evaluated communication strategies for patients unable to tolerate cuff deflation. Despite
      the aforementioned case reports, no studies report the feasibility of the Electrolarynx in
      restoring communication. Communication impairment during hospitalization has implications for
      the quality and safety of care as it is a modifiable risk factor for adverse events. This has
      led to accreditation organizations mandating reasonable efforts to establish alternative
      communication strategies for patients unable to speak. For chronically critically ill (CCI)
      patients, inability to speak increases anxiety, decreases a sense of control, and impairs
      meaningful patient involvement in decision making. Anxiety can exacerbate pain, which is
      known to impede ventilator weaning. Therefore it is likely that the inability to speak can
      impact negatively on weaning outcomes. 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.

      Overall Program of Research Hypothesis The investigators hypothesize that restoration of
      communication using the Electrolarynx can reduce patient anxiety resulting in improvement in
      weaning outcomes (weaning success and duration) and reduced adverse events associated with
      inability to communicate such as agitation, delirium, restraint use, and tube/line/device
      removal. Before being able to test this hypothesis, the feasibility of use of the
      Electrolarynx needs to be confirmed.

      Study Aim The aim of this study is to assess the feasibility of establishing speech with an
      Electrolarynx for patients receiving ventilation via an endotracheal tube or tracheostomy
      experiencing difficult weaning and unable to tolerate cuff deflation. Feasibility will be
      determined in terms of the proportion of participants able to produce intelligible and
      comprehensible speech as well as ease of, and satisfaction with communication.
    

Intervention name(s): Electrolarynx
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: communication; mechanical ventilation; weaning