The Feasibility of Measuring Energy Expenditure During Physical Rehabilitation In Critically Ill Patients

NCT02754622 | Completed

• 1 other identifier: 16/LO/0076
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Oxygen consumption during different physical rehabilitation activities.

  Measurements of oxygen consumption during physical rehabilitation activities whilst on ICU

  Through Critical Care stay, an average of 1 per day

• Carbon dioxide production during different physical rehabilitation activities.

  Measurements of carbon dioxide production during physical rehabilitation activities whilst on ICU

  Through Critical Care stay, an average of 1 per day

• Minute ventilation during different physical rehabilitation activities.

  Measurements of minute ventilation during physical rehabilitation activities whilst on ICU

  Through Critical Care stay, an average of 1 per day

Secondary Outcomes (1)

• Limitations of data acquisition using the indirect calorietry

  Through Critical Care stay, an average of 9 days

Study Arms (1)

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

Interventions

Observational Group OTHER

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

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Study Officials

• Bronwen Connolly

  Guys and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 28, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)