Decreasing Delirium Through Music in Critically Ill Older Adults (DDM)
B
Babar Khan, MD
Primary Investigator
Enrolling By Invitation
50 years and older
All
Phase
N/A
160 participants needed
3 Locations
Brief description of study
Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to
develop delirium, which predisposes them to longer lengths of ICU and hospital stay,d in-patient mortality, and higher risk of new acquired cognitive impairment and
dementia. Music listening is a non-pharmacological intervention that holds potential to
decrease ICU delirium. The investigators propose a randomized controlled trial to evaluatehe efficacy of a seven-day slow-tempo music intervention on the primary outcome of
delirium/coma free days among mechanically ventilated, critically ill older adults.
Detailed description of study
One million adults in the United States receive mechanical ventilation for acute respiratoryure in the intensive care units (ICUs) annually and up to 80% of them develop delirium
during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospitaluding a longer length of ICU and hospital stay, increased risk ofy and elevated costs of care. In addition, ICU delirium is associated withg-term post-discharge complications such as development of cognitive impairment and
dementia.
Recent research studies exploring pharmacological strategies to manage ICU delirium have not
demonstrated efficacy; a limitation also acknowledged in the Society of Critical Caredicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption
guidelines. Music listening is a non-pharmacological intervention that has shown to decreasever-sedation, anxiety and stress in critically ill patients, factors that could predisposeCU delirium. Our team is now proposing to conduct a large randomized clinical triald "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluatehe efficacy of a seven-day slow-tempo music intervention on the primary outcome of
delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Intensive Care Unit Delirium, Pain, Anxiety, Intensive Care Acquired Cognitive Impairment
-
Age: 50 Years
-
Gender: All
Inclusion Criteria:
- Age 50 years or older.
- English speaking.
- Admitted to the intensive care unit (medical or surgical).
- Expected mechanical ventilator support for ≥48 hours.
- Consentable through a legally authorized representative.
- Have access to a telephone.
Exclusion Criteria:
- History of dementing illnesses and other neurodegenerative diseases such asAlzheimer's disease or vascular dementia.
- Psychiatric illness which is not well controlled.
- Alcohol withdrawal symptoms/concern for withdrawal.
- Suspected or confirmed drug intoxication/overdose
- Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, orundergoing neurosurgery.
- Uncorrected hearing or vision impairment including legal blindness.
- Incarcerated at the time of study enrollment.
- Enrolled in another clinical trial which does not permit co-enrollment.
- Any medical condition precluding safe use of headphones such as: skin breakdown,burns, facial or skull fractures.
Updated on
01 Aug 2024.
Study ID: 1906664366
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