RecruitingACTRN12625000118404

Understanding Voice Problems in Adults Who Survived ICU Stays with a Breathing Machine: A Study from One Hospital

Assessment of Voice disorder among mechanically ventilated adult ICU survivors – A single-centre observational study (VOICE study)


Sponsor

Kiran Kumar Gudivada, Sr registrar/Fellow, Intensive Care Medicine, The Canberra Hospital

Enrollment

455 participants

Start Date

Apr 30, 2025

Study Type

Observational

Conditions

Summary

In hospitals, mechanical ventilation is crucial for critical conditions, commonly initiated in intensive care units through intubation. Unfortunately, about half of patients undergoing this process may suffer acute laryngeal injury, with limited information on its impact on post-ventilator speech. Our study focuses on how ventilator use for over 48 hours affects the voice in adult ICU patients. Utilising the vocal handicap index (VHI-10) and voice-related quality of life (V-RQOL), we measure the impact on voice and overall well-being at 8 weeks following ventilation. The VHI-10, a 10-question questionnaire, assesses the impact of voice problems, with scores above 11 indicating a significant impact. The V-RQOL questionnaire gauges the burden of these issues. Our findings are crucial for identifying predictive factors, enabling early intervention strategies like check-ups, speech therapies, and psychological support for those with voice issues, significantly improving their well-being.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When people are seriously ill in hospital, they are sometimes placed on a breathing machine (ventilator) through a tube inserted into their throat — a process called intubation. While this can be life-saving, the tube can sometimes injure the voice box (larynx), which may affect a person's voice after they leave the ICU. Research suggests this happens to about half of patients who are ventilated. This study is looking at how mechanical ventilation for 48 hours or more affects people's voices and quality of life. Eight weeks after being taken off the ventilator, participants will complete two short questionnaires — one that measures how much voice problems affect daily life, and another that measures the impact on overall wellbeing. The results will help doctors identify who might be at risk of voice problems after ICU care and what kinds of support or therapy might help. You may be eligible if you are an adult (18 or over) who was in the ICU and breathed with the help of a ventilator for at least 48 hours before transferring to a regular ward. People who had a tracheostomy, had previous voice box conditions, or received head and neck radiation in the past 6 months are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Our study focuses on how mechanical ventilation with endotracheal intubation for over 48 hours affects the voice in adult ICU patients. Utilizing the vocal handicap index (VHI-10) and voice-related qu

Our study focuses on how mechanical ventilation with endotracheal intubation for over 48 hours affects the voice in adult ICU patients. Utilizing the vocal handicap index (VHI-10) and voice-related quality of life (V-RQOL), we measure the impact on voice and overall well-being. The VHI-10, a 10-question questionnaire, assesses the impact of voice problems, with scores above 11 indicating a significant impact. The V-RQOL questionnaire gauges the burden of these issues. Both these Questionnaires will be given to patients at 8 weeks after liberation from mechanical ventilation. Each questionnaire contains 10 items and it takes approximately 3-4 minutes to complete each questionnaire and 8 minutes in total to complete these self assessment forms.


Locations(1)

The Canberra Hospital - Garran

ACT, Australia

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ACTRN12625000118404