There is a need to know more about the safety of mobilizing intensive care unit (ICU) patients who are receiving vasoactive drugs that support the heart and blood pressure. But before this research can be done, several uncertainties need to be addressed. To answer these uncertainties, the investigators will ask ICU patients receiving vasoactive drugs to take part in a study in three main stages. Firstly ICU patients will be asked whether they would be happy to take part in a future research trial on the safety of mobilizing patients who are receiving vasoactive drugs. Secondly, data will be collected about the current mobilization on vasoactive drugs that occurs. Finally, the investigators will try to follow up these patients 60 days after they start the study, to carry out some questionnaires and a walking test with the patients. These tests may be used in future research to measure the effect of mobilizing patients on vasoactive drugs.
The current evidence is insufficient to accurately guide clinicians to know when it is safe to start mobilizing intensive care unit (ICU) patients receiving vasoactive drugs. Before a randomized controlled trial can be designed, several uncertainties need to be addressed. This includes clarifying what standard care is, what potential recruitment rates would be and what the most suitable primary outcome measure is. This study is an exploratory observational study which will aim to recruit up to 40 ICU patients receiving vasoactive drugs to further clarify standard care and to measure preliminary feasibility outcomes. Upon enrolment, patients and clinicians will be surveyed about the hypothetical acceptability of recruitment into a future randomized controlled trial. Then any routine mobilization that occurs whilst the patient is receiving vasoactive drugs will be analyzed, for example, to describe how clinicians assessed safety for mobilization. Finally, patient participants will be followed up at day 60 to assess the feasibility of measuring candidate primary outcome measures.
Study Type
OBSERVATIONAL
Enrollment
100
Physical rehabilitation
Imperial College Healthcare NHS Trust
London, United Kingdom
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Time frame: Baseline (approximately one day from enrolment)
Number of Participants With Follow-up at 60 Days
Patient participant follow-up rate at 60 days.
Time frame: 60 days
Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities.
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid frailty.
Time frame: Baseline (approximately one day from enrolment)
Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
Quantity of missing data resulting from measurement of participant pre-morbid physical function.
Time frame: Baseline (approximately one day from enrolment)
Who Made the Final Decision Whether to Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.
Time frame: Through duration of ICU stay (average of 7 days).
The Reasons for the Decision When Patient Was Mobilized.
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized. Qualitative measure: reasons underwent content analysis, with the outcome being the themes summarizing the reasons.
Time frame: Through duration of ICU stay (average of 7 days).
Who Made the Final Decision Whether to Not Mobilize the Patient
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.
Time frame: Through duration of intensive care stay (average 7 days)
The Reasons for the Decision When the Patient Was Not Mobilized.
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized. Qualitative variable: reasons underwent qualitative analysis, with the output of a list of themes summarizing the reasons.
Time frame: Through duration of intensive care stay (average 7 days)
The Reason Why a Mobilisation Treatment Was Stopped
Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.
Time frame: Through duration of ICU stay (average of 7 days).
Number of Serious Adverse Events
Number of serious adverse events
Time frame: Through whole of study, an estimated 6 months
Number of ICU Physical Rehabilitation Adverse Events
Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review.
Time frame: Through duration of ICU stay (average of 7 days).
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out.
Time frame: Through duration of ICU stay (average of 7 days).
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Tool completed both by treating clinician and by researcher case note review. Number of mobilization treatment sessions on vasoactive drugs where adverse event tool is complete.
Time frame: Through duration of ICU stay (average of 7 days).
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
A survey measuring user opinion on whether an adverse event tool was for example understandable and an appropriate length using a scale with 'yes', 'no' or 'unsure' responses. Survey adapted from Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., Young, P., Zanni, J., Buhr, H., Higgins, A., Presneill, J. \& Berney, S. 2014. Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung, 43.
Time frame: Through second half of the study, an estimated 3 months
Time to First Mobilisation Treatment
Number of days to first rehabilitation treatment
Time frame: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Sit Out of Bed.
Regardless of the assistance required.
Time frame: Through duration of hospital stay (average of 22 days)
Time to First Being Able to Stand.
Regardless of the assistance required.
Time frame: Through duration of hospital stay (average of 22 days).
Time to First Being Able to Walk.
Regardless of assistance required.
Time frame: Through duration of hospital stay (average of 22 days).
Intensive Care Unit Length of Stay.
Time frame: From admission to ICU discharge (an average of 7 days)
Hospital Length of Stay
Time frame: From admission to hospital discharge (average of 22 days)
Intensive Care Unit Mobility Scale Level at ICU Discharge.
Intensive care unit mobility scale records a patient's mobility level from 0 to 10, where 0 means no mobility and 10 means walking without assistance from people or a physical aid.
Time frame: ICU discharge (an average of 7 days from ICU admission)
Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Time frame: 60 days.
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Time frame: 60 days.
Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
Measures of central tendency and variability of data for candidate outcome measures to inform a sample size for future randomised controlled trial, e.g. physical functioning measured by the physical function domain of the RAND 36-Item Health Survey 1.0 Questionnaire (RAND SF-36 v1), scores range from 0-100, where a higher score means better physical functioning.
Time frame: 60 days.
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