Clinical Trials Logo

Clinical 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, 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05604079
Study type Interventional
Source Michael Garron Hospital
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT05203146 - PIMPmyHospital: a Mobile App to Improve Emergency Care Efficiency and Communication N/A
Completed NCT04105751 - Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Completed NCT05540444 - RadConnect Communication Application
Recruiting NCT04317664 - Intervention to Improve Driving Practices Among High-Risk Teen Drivers Phase 3
Completed NCT05812599 - Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers N/A
Completed NCT03221985 - ESM Pilot: Mobile Phones and Psychology N/A
Completed NCT02267265 - Pilot Study of Novel Postpartum Educational Video Intervention N/A
Completed NCT03203018 - Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities N/A
Completed NCT02619474 - The Effect of Whiteboards on Patient Satisfaction N/A
Completed NCT02695316 - Barrier-free Communication in Maternity Care of Allophone Migrants N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01697137 - Patient and Physician Intervention to Increase Organ Donation N/A
Completed NCT01459744 - An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Completed NCT01040975 - Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight N/A
Completed NCT03044145 - The Cultural Formulation Interview-Engagement Aid N/A
Recruiting NCT04533126 - Channels of Communication & Brain Functioning: Pilot fMRI Study
Withdrawn NCT03901547 - Emotion Regulation and Burnout Impact on Communication Documentation N/A
Completed NCT06081660 - Advance Care Planning for Older Latinos With Chronic Illness N/A