CommunicationEECCHONCT05604079
Electrolarynx for Enabling Communication in the CHrOnically Critically Ill (EECCHO)
A study testing Electrolarynx in people with Communication, run by Michael Garron Hospital at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Communication
- What is being tested?
- Electrolarynx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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..
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Saint Michael's Hospital
Toronto, Ontario
Sunnybrook Health Care Centre
Toronto, Ontario
About this study
Official title: Feasibility Assessment of the Electrolarynx for Enabling Communication in the
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.
Read the 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.
- Conditions
- Communication
- Being tested
- Electrolarynx
- Keywords
- communication, mechanical ventilation, weaning
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrolarynxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrolarynx | Experimental | In this single arm study, all participants will receive training in the Electrolarynx Receives: Device: Electrolarynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 days of training
Secondary outcomes (6)
Perceived ease and satisfaction with use
The investigators will use a simplified form of the Ease of Communication scale developed by Menzel that has been adapted and used in studies assessing communication in non-vocal ICU patients. We will use a 5-point Likert type scale to measure satisfaction with 1 indicating very satisfied and 5 indicating not at all satisfied.
Measured: Within 5 days of training
Training time
The investigators will record the total time spent to train each participant to use the Electrolarynx
Measured: Commencement and completion of training - training is a maximum of five days
Anxiety
The investigators will measure anxiety using the Faces Anxiety Scale
Measured: Within 5 days of training
Consent rate
The investigators will document the number of participants that consent and decline
Measured: One month after completion of study recruitment
Time to complete research measures
The investigators will record the time to complete all research procedures
Measured: One month after completion of study recruitment
Effectiveness of the Electrolarynx
The investigators will measure the effectiveness of the Electrolarynx for communication using the Electrolarynx Effectiveness Score
Measured: Within 5 days of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study startNov 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Garron Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Unity Health Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604079
- Sponsor's protocol ID
- TorontoEGH
- Acronym
- EECCHO
- Status last verified
- May 2021
- First submitted
- 5 Jan 2015
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of the Electrolarynx for Enabling Communication in the
- ClinicalTrials.gov ID
- NCT05604079
- Acronym / sponsor ID
- EECCHO / TorontoEGH
- Conditions
- Communication
- Keywords
- communication, mechanical ventilation, weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Michael Garron HospitalUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Unity Health Toronto
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrolarynx | Experimental | Device: ElectrolarynxIn this single arm study, all participants will receive training in the Electrolarynx |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrolarynxThe 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. | Device | Electrolarynx |
Primary outcome
Feasibility of the Electrolarynx for establishing successful communication defined as the ability to generate speech that is intelligible and comprehensible
Time frame: Within 5 days of training
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.
6 secondary outcomes
Perceived ease and satisfaction with use
Time frame: Within 5 days of training
Training time
Time frame: Commencement and completion of training - training is a maximum of five days
Anxiety
Time frame: Within 5 days of training
Consent rate
Time frame: One month after completion of study recruitment
Time to complete research measures
Time frame: One month after completion of study recruitment
Effectiveness of the Electrolarynx
Time frame: Within 5 days of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolarynx in people with Communication, run by Michael Garron Hospital at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Electrolarynx for establishing successful communication defined as the ability to generate speech that is intelligible and comprehensible (time frame: Within 5 days of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.