Exploration of Investigating ICU Mobilisation With Vasoactive Drugs

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869541
• Other study ID #: 18SM4731
• Status: Completed
• Start date: December 14, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: October 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Mobilization
Physical rehabilitation

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (approximately one day from enrolment)
Primary	Number of Participants With Follow-up at 60 Days	Patient participant follow-up rate at 60 days.	60 days
Secondary	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	Baseline (approximately one day from enrolment)
Secondary	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	Baseline (approximately one day from enrolment)
Secondary	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	Baseline (approximately one day from enrolment)
Secondary	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.	Baseline (approximately one day from enrolment)
Secondary	Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.	Quantity of missing data resulting from measurement of participant pre-morbid frailty.	Baseline (approximately one day from enrolment)
Secondary	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.	Baseline (approximately one day from enrolment)
Secondary	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.	Through duration of ICU stay (average of 7 days).
Secondary	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.	Through duration of ICU stay (average of 7 days).
Secondary	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.	Through duration of intensive care stay (average 7 days)
Secondary	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.	Through duration of intensive care stay (average 7 days)
Secondary	The Reason Why a Mobilisation Treatment Was Stopped	Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.	Through duration of ICU stay (average of 7 days).
Secondary	Number of Serious Adverse Events	Number of serious adverse events	Through whole of study, an estimated 6 months
Secondary	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.	Through duration of ICU stay (average of 7 days).
Secondary	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.	Through duration of ICU stay (average of 7 days).
Secondary	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.	Through duration of ICU stay (average of 7 days).
Secondary	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.	Through second half of the study, an estimated 3 months
Secondary	Time to First Mobilisation Treatment	Number of days to first rehabilitation treatment	Through duration of hospital stay (average of 22 days)
Secondary	Time to First Being Able to Sit Out of Bed.	Regardless of the assistance required.	Through duration of hospital stay (average of 22 days)
Secondary	Time to First Being Able to Stand.	Regardless of the assistance required.	Through duration of hospital stay (average of 22 days).
Secondary	Time to First Being Able to Walk.	Regardless of assistance required.	Through duration of hospital stay (average of 22 days).
Secondary	Intensive Care Unit Length of Stay.		From admission to ICU discharge (an average of 7 days)
Secondary	Hospital Length of Stay		From admission to hospital discharge (average of 22 days)
Secondary	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.	ICU discharge (an average of 7 days from ICU admission)
Secondary	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.	60 days.
Secondary	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.	60 days.
Secondary	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.	60 days.