Gastric Ultrasound in Tube Fed Intubated Patients
NCT04612348
Critical Illness, Disease Attributes
Columbus, Ohio, United States
View Trial DetailsNCT Number: NCT03141762
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
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Notify Me18 year and older
All sexes
Observational
Melbourne Health, Melbourne, Victoria, Australia
This observational study aims to investigate the incidence and risk factors for falls in the first 12 months post hospital discharge in patients following an ICU admission. It also aims to determine factors at hospital discharge which may predict future falls risk at 12 months and examine the physical activity levels of ICU survivors. Furthermore, it also will investigate the relationship between falls, fear of falling and activity limitations and participation restriction. All adult patients in intensive care that have been mechanically ventilated for over 48 hours, and remain in the ICU at least 4 days will be considered for inclusion. The primary outcome measure is a 12 month falls diary which commences on hospital discharge. There will also be Physiotherapy assessments just prior to hospital discharge, 3, 6, and 12 months post hospital discharge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: One per month for 12 months
12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.
Time frame: Baseline, 3, 6, and 12 months post discharge
Ultrasound of rectus femoris and tibialis anterior
Time frame: Baseline, 3, 6, and 12 months post discharge
Muscle strength
Time frame: Baseline, 3, 6, and 12 months post discharge
Balance
Time frame: Baseline, 3, 6, and 12 months post discharge
Gait
Time frame: Baseline, 3, 6, and 12 months post discharge
Cognitive
Time frame: Baseline, 3, 6, and 12 months post discharge
Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.
Time frame: Baseline, 3, 6, and 12 months post discharge
Frailty
Time frame: 3, 6, and 12 months post discharge
Falls risk
Time frame: Baseline, 3, 6, and 12 months post discharge
Individuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities.
Time frame: Baseline, 3, 6, and 12 months post discharge
It is a self-rating scale that measures anxiety and depression in both hospital and community settings.
Time frame: Baseline, 3, 6, and 12 months post discharge
Self-reported health-related quality of life questionnaire.
Time frame: Baseline, 3, 6, and 12 months post discharge
It is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week.
Time frame: Baseline, 3, 6, and 12 months post discharge
physical test evaluation of balance, strength, and walking ability
Time frame: 3, 6, and 12 months post discharge
Categorise readmissions and what health services are used post hospital discharge
Time frame: 3, 6 and 12 months
Fatigue levels self report questionnaire
Time frame: 3, 6, and 12 months
Weekend and weekday questionnaire of sedentary behaviour in hours
Time frame: 3, 6, and 12 months
self report resilience questionnaire
Time frame: 3, 6, and 12 months
10 item self report optimism scale, higher scores indicate higher optimism
Time frame: 3, 6, and 12 months
questionnaire that evaluates sleep quality, higher scores indicate poorer sleep
Time frame: 3, 6, and 12 months
short questionnaire which asks patients to rate their top problems and activity limitations
Time frame: 3, 6, and 12 months
questionnaire which covers different symptoms and how much it bothers the patient on a likert scale
Time frame: 3, 6 and 12 months
questionnaire which provides time to return to work and impact on finances
University of Melbourne
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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