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The Feasibility of Measuring Energy Expenditure During Physical Rehabilitation In Critically Ill Patients (ENERGY-ICU)

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ClinicalTrials.gov Identifier: NCT02754622
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

Many patients who are admitted to the intensive care unit (ICU) experience muscle weakness. This muscle weakness occurs whilst patients are unconscious, immobile in bed and on a breathing machine (ventilator). It can develop very quickly, as soon as they become unwell. The investigators know that this weakness can make it harder for patients to regain their normal level of functional ability, such as standing and walking independently. Physical rehabilitation, delivered by physiotherapists, is important for patients as they recover from their critical illness to help them regain strength and to practice the ability to perform physical activities. These activities include sitting on the edge of the bed, standing, stepping on the spot and walking.

However it is difficult to know how hard it is for patients who are recovering from critical illness to perform these types of activities - in other words, how much energy is required. Some patients may find certain activities harder or easier than others. By knowing the energy requirements of patients whilst they take part in different physical rehabilitation activities, physiotherapists may be able to be more accurate with prescribing exercises and designing rehabilitation sessions for patients to practice achieving those activities.

In this study, the investigators will measure the energy requirements of the patients when they take part in physiotherapy-led physical rehabilitation they will have during their admission. To do this, the investigators will use a different ventilator to the one normally used to help their breathing. This ventilator works in exactly the same way, but has an extra component built into it to measure energy requirements. After the rehabilitation session, the patient will return to using their normal ventilator.


Condition or disease Intervention/treatment
Intensive Care Other: Observational Group

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Observational Cohort Study Examining the Feasibility of Measuring Energy Expenditure During Physical Rehabilitation In Critically Ill Patients
Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Group/Cohort Intervention/treatment
Observational Group
  • 2hours before planned physical rehabilitation patients will have their regular ventilator changed to the study ventilator by an ICU Consultant and patients will be clinical stable for 30mins prior to the start of the planned physical rehabilitation.
  • Intended physical rehabilitation as planned will continue without change. This session will be observed by a member of the research team to ensure accurate documentation of the exact timing of performance of the physical rehabilitation activity.
  • Patients will also undergo an assessment by the Medical Research Council Sum-score and maximal inspiratory pressure (all part of routine physiotherapy assessment).
  • Following the physical rehabilitation session, the patient to rate their perceived exertion then patients will also undergo ultrasound assessment of peripheral skeletal muscle architecture.
  • Patients return to their original ventilator after 30mins by an ICU Consultant.
Other: Observational Group
Indirect calorimetry measurement during Physical Rehabilitation. Observing planned physical rehabilitation session to determine the rehabilitation activity achieved with IC utilised to determine the number of calories used per session




Primary Outcome Measures :
  1. Oxygen consumption during different physical rehabilitation activities. [ Time Frame: Through Critical Care stay, an average of 1 per day ]
    Measurements of oxygen consumption during physical rehabilitation activities whilst on ICU

  2. Carbon dioxide production during different physical rehabilitation activities. [ Time Frame: Through Critical Care stay, an average of 1 per day ]
    Measurements of carbon dioxide production during physical rehabilitation activities whilst on ICU

  3. Minute ventilation during different physical rehabilitation activities. [ Time Frame: Through Critical Care stay, an average of 1 per day ]
    Measurements of minute ventilation during physical rehabilitation activities whilst on ICU


Secondary Outcome Measures :
  1. Limitations of data acquisition using the indirect calorietry [ Time Frame: Through Critical Care stay, an average of 9 days ]
    Measuring the quality of data acquired to identify technical issues, pragmatic factors, number of rehabilitation sessions by eligible patients and limiting factors to use of the indirect calorimetry.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult critically ill patients undergoing physical rehabilitation in either the Intensive Care Units or the Lane Fox Unit at Guys and St Thomas' NHS Foundation Trust.
Criteria

Inclusion Criteria:

  • Adult, ≥18years
  • Receiving physical rehabilitation as part of routine physiotherapy management
  • Invasively mechanically ventilated for ≥48hours
  • Receiving invasive mechanical ventilation with stable settings

Exclusion Criteria:

  • Endotracheal or tracheal leak >10%
  • Burns
  • Open chest drainage
  • Inspired oxygen (FiO2) ≥0.6
  • Extra-corporeal membrane oxygenation (ECMO)
  • Pregnancy
  • Cardiorespiratory instability requiring frequent adjustment of ventilator settings or FiO2, inotropic or sedative dosage, or positive end-expiratory pressure (PEEP) >10cmH2O
  • Any neurological, orthopaedic or other factor contraindicating mobilisation
  • Medical diagnosis mandating a specialist rehabilitation pathway e.g. amputee, acute neurological injury
  • Palliative management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754622


Locations
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United Kingdom
Guys and St Thomas NHS Foundation
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Bronwen Connolly Guys and St Thomas NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02754622     History of Changes
Other Study ID Numbers: 16/LO/0076
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Rehabilitation

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes