Critical Care Clinical Trial
— FICEOfficial title:
Feeding With Indirect Calorimetry and Cycling in the Elderly Intensive Care Patient
Verified date | June 2023 |
Source | National University Hospital, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effect of early exercise by cycle ergometry and early targeted feeding in reducing muscle atrophy and improve functional outcomes in the older critically ill patient.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. At least 60 years old 2. Mechanically ventilated within 3 days of ICU admission 3. Expected to be mechanically ventilated for more than 3 days at time of recruitment 4. Able to ambulate with or without a gait aid before hospitalization 5. Able to be enterally fed within 48 hours of ICU admission Exclusion Criteria: 1. Unable to follow commands at baseline before hospital admission (e.g. Severe dementia) 2. Acute condition where cycling is a contraindication (e.g. leg fracture) 3. Not expected to survive the subsequent 48 hours 4. Body habitus unable to fit the cycle ergometry 5. Patients at high risk of refeeding (i.e. NUTRIC score >= 5): malnourished patients with anorexia nervosa, chronic malabsorption syndromes, chronic alcoholism, or patients with massive weight loss. 6. Extremes of BMI: i.e. BMI < 16 or > 30 7. Liver failure 8. Cycling exemptions precluding cycling within the first 4 days of mechanical ventilation 9. Requirement for inspired oxygen content (FiO2) greater than 0.8 10. Expected to be on renal replacement therapy for longer than 12 hours per session 11. PEEP > 15mmHg 12. Air leaks through chest drains 13. Palliative goals of care or limitation of treatment established by the CARE form 14. Readmissions to ICU |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Health System | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Singapore,
Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016. — View Citation
Parry SM, Huang M, Needham DM. Evaluating physical functioning in critical care: considerations for clinical practice and research. Crit Care. 2017 Oct 4;21(1):249. doi: 10.1186/s13054-017-1827-6. — View Citation
Petros S, Engelmann L. Validity of an abbreviated indirect calorimetry protocol for measurement of resting energy expenditure in mechanically ventilated and spontaneously breathing critically ill patients. Intensive Care Med. 2001 Jul;27(7):1164-8. doi: 10.1007/s001340100941. — View Citation
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation
Reid CL. Poor agreement between continuous measurements of energy expenditure and routinely used prediction equations in intensive care unit patients. Clin Nutr. 2007 Oct;26(5):649-57. doi: 10.1016/j.clnu.2007.02.003. Epub 2007 Apr 6. — View Citation
Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21. — View Citation
Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22. — View Citation
Wei X, Day AG, Ouellette-Kuntz H, Heyland DK. The Association Between Nutritional Adequacy and Long-Term Outcomes in Critically Ill Patients Requiring Prolonged Mechanical Ventilation: A Multicenter Cohort Study. Crit Care Med. 2015 Aug;43(8):1569-79. doi: 10.1097/CCM.0000000000001000. — View Citation
Wichansawakun S, Meddings L, Alberda C, Robbins S, Gramlich L. Energy requirements and the use of predictive equations versus indirect calorimetry in critically ill patients. Appl Physiol Nutr Metab. 2015 Feb;40(2):207-10. doi: 10.1139/apnm-2014-0276. Epub 2014 Oct 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in quadriceps muscle thickness | Change in quadriceps muscle thickness | Change in thickness of quadriceps muscle (as assessed by ultrasound scanning) over the first 2 weeks of study. | |
Secondary | MRC-ss | Measurement of functional outcome. | On discharge from ICU, up to 1 year from recruitment. | |
Secondary | MRC-ss | Measurement of functional outcome. | 14 days after recruitment | |
Secondary | MRC-ss | Measurement of functional outcome. | On discharge from hospital, up to 1 year from recruitment. | |
Secondary | FSS-ICU | Measurement of functional outcome. | On discharge from ICU, up to 1 year from recruitment. | |
Secondary | FSS-ICU | Measurement of functional outcome. | 14 days after recruitment | |
Secondary | FSS-ICU | Measurement of functional outcome. | On discharge from hospital, up to 1 year from recruitment. | |
Secondary | CPax | Measurement of functional outcome. | On discharge from ICU, up to 1 year from recruitment. | |
Secondary | CPax | Measurement of functional outcome. | 14 days after recruitment | |
Secondary | CPax | Measurement of functional outcome. | On discharge from hospital, up to 1 year from recruitment. | |
Secondary | Quadriceps strength and hand grip strength | Measured with dynamometer. | On discharge from ICU, up to 1 year from recruitment. | |
Secondary | Quadriceps strength and hand grip strength | Measured with dynamometer. | 14 days after recruitment | |
Secondary | Quadriceps strength and hand grip strength | Measured with dynamometer. | On discharge from hospital, up to 1 year from recruitment. | |
Secondary | Length of Stay in ICU | Length of Stay in ICU | Day of discharge from ICU, up to 1 year from recruitment. | |
Secondary | Length of hospital stay | Length of hospital stay | Day of discharge from hospital, up to 1 year from recruitment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05114551 -
ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
|
||
Completed |
NCT05547646 -
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
|
||
Recruiting |
NCT03697785 -
Weaning Algorithm for Mechanical VEntilation
|
N/A | |
Completed |
NCT02922101 -
Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care
|
N/A | |
Completed |
NCT02902783 -
DONATE-Pilot Study on ICU Management of Deceased Organ Donors
|
||
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT01857986 -
Evaluating Air Leak Detection in Intubated Patients
|
N/A | |
Recruiting |
NCT05518955 -
VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU
|
N/A | |
Recruiting |
NCT03810768 -
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
|
||
Completed |
NCT03295630 -
Validity of an Actigraph Accelerometer Following Critical Illness
|
N/A | |
Completed |
NCT05556811 -
HEaling LIght Algorithms for the ICU Patient
|
N/A | |
Recruiting |
NCT05702411 -
Air Stacking Technique For Pulmonary Reexpansion
|
N/A | |
Completed |
NCT02741453 -
Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement
|
N/A | |
Recruiting |
NCT04979897 -
Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
|
||
Completed |
NCT05281224 -
Ventilator Tube Holder for Patients With a Tracheostomy
|
||
Withdrawn |
NCT02970903 -
VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU
|
N/A | |
Recruiting |
NCT02587273 -
The Pharmacokinetics of Fentanyl in Intensive Care Patients
|
Phase 4 | |
Completed |
NCT02661607 -
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
|
N/A | |
Completed |
NCT01479153 -
Venous Site for Central Catheterization
|
N/A | |
Recruiting |
NCT06110390 -
High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients
|
N/A |