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NCT Number: NCT03869541

Exploration of Investigating ICU Mobilisation With Vasoactive Drugs

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patient participants:

Inclusion criteria

  • Patients admitted to the ICU who are receiving vasoactive drugs.
  • Age greater than or equal to 18 years old.
  • Expected to remain admitted to the ICU for at least 24 hours post-enrolment.

Exclusion criteria

  • Any patient who is expected to die imminently, as per clinical opinion.
  • Any patient where mobilization is contraindicated by the nature of their existing injuries.
  • Where it is clear from the medical records that participants are prisoners or offenders on probation.
  • Patients with neuromuscular disease or acute brain injury or spinal cord injury.
  • If the patient and/or their consultee is unable to speak English.

Clinicians participating in a survey on hypothetical randomization of patient participants:

Inclusion criteria

  • Clinicians who work in the intensive care unit where a patient participant has been admitted.

Exclusion criteria

  • None.

Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:

Inclusion criteria

  • An ICU clinician at the research site.
  • Has used the ICU physical rehabilitation adverse event tool as part of this research study.

Exclusion criteria

  • None.

Treatment and study plan

Mobilization

Other

Physical rehabilitation

Primary outcomes

  1. Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.

    Time frame: Baseline (approximately one day from enrolment)

    The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.

  2. Number of Participants With Follow-up at 60 Days

    Time frame: 60 days

    Patient participant follow-up rate at 60 days.

Secondary outcomes

  1. Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable

    Time frame: Baseline (approximately one day from enrolment)

    Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation

  2. Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable

    Time frame: Baseline (approximately one day from enrolment)

    Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care

  3. Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable

    Time frame: Baseline (approximately one day from enrolment)

    Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care

  4. Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.

    Time frame: Baseline (approximately one day from enrolment)

    Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities.

  5. Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.

    Time frame: Baseline (approximately one day from enrolment)

    Quantity of missing data resulting from measurement of participant pre-morbid frailty.

  6. Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.

    Time frame: Baseline (approximately one day from enrolment)

    Quantity of missing data resulting from measurement of participant pre-morbid physical function.

  7. Who Made the Final Decision Whether to Mobilize the Patient

    Time frame: Through duration of ICU stay (average of 7 days).

    Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.

  8. The Reasons for the Decision When Patient Was Mobilized.

    Time frame: Through duration of ICU stay (average of 7 days).

    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.

  9. Who Made the Final Decision Whether to Not Mobilize the Patient

    Time frame: Through duration of intensive care stay (average 7 days)

    Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.

  10. The Reasons for the Decision When the Patient Was Not Mobilized.

    Time frame: Through duration of intensive care stay (average 7 days)

    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.

  11. The Reason Why a Mobilisation Treatment Was Stopped

    Time frame: Through duration of ICU stay (average of 7 days).

    Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.

  12. Number of Serious Adverse Events

    Time frame: Through whole of study, an estimated 6 months

    Number of serious adverse events

  13. Number of ICU Physical Rehabilitation Adverse Events

    Time frame: Through duration of ICU stay (average of 7 days).

    Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review.

  14. Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.

    Time frame: Through duration of ICU stay (average of 7 days).

    Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out.

  15. Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.

    Time frame: Through duration of ICU stay (average of 7 days).

    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.

  16. Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.

    Time frame: Through second half of the study, an estimated 3 months

    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.

  17. Time to First Mobilisation Treatment

    Time frame: Through duration of hospital stay (average of 22 days)

    Number of days to first rehabilitation treatment

  18. Time to First Being Able to Sit Out of Bed.

    Time frame: Through duration of hospital stay (average of 22 days)

    Regardless of the assistance required.

  19. Time to First Being Able to Stand.

    Time frame: Through duration of hospital stay (average of 22 days).

    Regardless of the assistance required.

  20. Time to First Being Able to Walk.

    Time frame: Through duration of hospital stay (average of 22 days).

    Regardless of assistance required.

  21. Intensive Care Unit Length of Stay.

    Time frame: From admission to ICU discharge (an average of 7 days)

  22. Hospital Length of Stay

    Time frame: From admission to hospital discharge (average of 22 days)

  23. Intensive Care Unit Mobility Scale Level at ICU Discharge.

    Time frame: ICU discharge (an average of 7 days from ICU admission)

    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.

  24. Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.

    Time frame: 60 days.

    Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.

  25. The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.

    Time frame: 60 days.

    Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.

  26. Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.

    Time frame: 60 days.

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Investigating the Safety of Mobilising Intensive Care Unit Patients Receiving Vasoactive Drugs: An Exploratory Observational Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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