Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patie… (NCT03406494) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
800 participantsStarted 2018-03
Plain-language summary
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.
Who can participate
Age range16 Years – 75 Years
SexALL
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Inclusion criteria
✓. Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.
✓. 16 ≤ age ≤ 75 years.
✓. Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.
✓. Ability to obtain informed consent from patient or proxy.
Exclusion criteria
✕. acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).
✕. active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).
✕. severe thoracic or abdominal trauma.
✕. acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.
✕. drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.
What they're measuring
1
ICU 28-day mortality
Timeframe: Through 28-day study period in the ICU.