Status:
RECRUITING
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Intensive Care Unit Acquired Weakness
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop complications such as intensive care unit acquired weakness (ICUAW) characterized by limb and r...
Detailed Description
Critical illness is related to high morbidity and mortality rates, and health-care costs. Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop compl...
Eligibility Criteria
Inclusion
- Full cooperatively adult patients indicated by the Adequacy Score of standardized 5 questions (SQ5) = 5/5
- Patients mechanically ventilated for longer than 48 hours during the same ICU admission
- Patients are expected to remain in the ICU for more than an additional 48 hours starting from study enrollment
- Patients able to perform active cycling for \> 10 consecutive minutes
Exclusion
- Pre-existing functional limitations
- Low limb injuries or conditions that would preclude in-bed cycling such as a body habitus unable to fit the bike
- Extreme obesity (body mass index \>35 kg/m2)
- Neurologically unstable
- Acute surgery
- Palliative goals of care
- Temperature \> 40 °C
- An anticipated fatal outcome
- Evidence of coronary ischaemia, for example, chest pain or electrocardiogram changes
- Resting heart rate \<40 or \>120 beats per minute
- Mean arterial pressure \<60 or \>120 mmHg
- Peripheral capillary oxygen saturation \< 90%
- Wounds, trauma or surgery of leg precluding cycle ergometry
- Wounds, trauma or surgery of pelvis precluding cycle ergometry
- Wounds, trauma or surgery of lumbar spine precluding cycle ergometry
- Coagulation disorder (international normalised ratio \> 1.8, or platelets \< 50,000 mcL)
- Intracranial pressure \>20 mm Hg
- Femoral access other than femoral central line
- Acute deep vein thrombosis
- Pulmonary embolism
- \>20 mcg/min of noradrenaline
- inotropic or vasopressor support comparable to a dose of noradrenaline \>20mcg/min
- Fraction of inspired oxygen \> 55%
- Arterial partial pressure of oxygen (PaO2) \<65 torr (\<8.66 kPa)
- Positive end-expiratory pressure \> 10 cmH2O
- Respiratory rate \> 30 breaths per minutes with adequate ventilatory support
- Minute ventilation \>150 mL/kg body weight
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05279547
Start Date
February 1 2023
End Date
December 1 2026
Last Update
June 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Leuven
Leuven, Belgium, 3000