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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive care patients | Adult intensive care patients receiving vasoactive drugs |
| |
| Intensive care unit clinicians | Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. | ||
| ICU rehabilitation clinicians | Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobilization | Other | Physical rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Participants With Follow-up at 60 Days | Patient participant follow-up rate at 60 days. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable |
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Patient participants:
Inclusion Criteria:
Exclusion Criteria:
Clinicians participating in a survey on hypothetical randomization of patient participants:
Inclusion criteria:
Exclusion criteria:
Clinician participants in the survey on the feasibility of the ICU physical rehabilitation adverse event tool:
Inclusion criteria:
Exclusion criteria:
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Intensive care unit patients and clinicians.
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Gordon, Prof | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Care Patients | Adult intensive care patients receiving vasoactive drugs Mobilization: Physical rehabilitation |
| FG001 | Intensive Care Unit Clinicians | Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. |
| FG002 | ICU Rehabilitation Clinicians | Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Care Patients | Adult intensive care patients receiving vasoactive drugs Mobilization: Physical rehabilitation |
| BG001 | Intensive Care Clinicians | Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not recorded for intensive care clinicians or intensive care rehabilitation clinicians. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants without missing data for this outcome | Posted | Count of Participants | Participants | Baseline (approximately one day from enrolment) |
|
|
Intensive care patients: 60 days Intensive care unit clinicians: From time of enrolment to timepoint in study where no further questionnaires were required of this study arm (length of time variable as a clinician participant could take part in one or multiple questionnaires depending if they were completing a clinical shift when a patient participant was recruited). ICU rehabilitation clinicians: From time of enrolment to time that questionnaire was returned to researcher.
This study was observational (not involving changes to standard care) therefore we only monitored for and report adverse events and serious adverse events that are related to study procedures which involve contact with the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Care Patients | Adult intensive care patients receiving vasoactive drugs Mobilization: Physical rehabilitation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huw Woodbridge | Imperial College London | +44 (0)20 7594 3192 | h.woodbridge@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2019 | Mar 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through duration of ICU stay (average of 7 days). |
| Number of Serious Adverse Events | Number of serious adverse events | 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. | 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. | 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. | 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. | Through second half of the study, an estimated 3 months |
| Time to First Mobilisation Treatment | Number of days to first rehabilitation treatment | Through duration of hospital stay (average of 22 days) |
| Time to First Being Able to Sit Out of Bed. | Regardless of the assistance required. | Through duration of hospital stay (average of 22 days) |
| Time to First Being Able to Stand. | Regardless of the assistance required. | Through duration of hospital stay (average of 22 days). |
| Time to First Being Able to Walk. | Regardless of assistance required. | Through duration of hospital stay (average of 22 days). |
| Intensive Care Unit Length of Stay. | From admission to ICU discharge (an average of 7 days) |
| Hospital Length of Stay | 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. | 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. | 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. | 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. | 60 days. |
| BG002 | Intensive Care Rehabilitation Clinicians | Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. |
| BG003 | Total | Total of all reporting groups |
Data only collected for Intensive care patients arm for this baseline measure.
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Not recorded for intensive care clinicians or intensive care rehabilitation clinicians. | Data only collected for Intensive care patients arm for this baseline measure. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Not recorded for intensive care clinicians or intensive care rehabilitation clinicians. | Data only collected for Intensive care patients arm for this baseline measure. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Not recorded for intensive care clinicians or intensive care rehabilitation clinicians. | Number analysed in row differs from overall due to missing data. Data only collected for Intensive care patients arm for this baseline measure. | Median | Inter-Quartile Range | kg/m^2 |
|
| APACHE (Acute physiology and chronic health evaluation)II score | A severity of disease classification system. A scale of 0 to 71, with a higher score equating to more severe disease and mortality risk. Not recorded for intensive care clinicians or intensive care rehabilitation clinicians. | Data only collected for Intensive care patients arm for this baseline measure. | Median | Inter-Quartile Range | units on a scale |
|
| Sequential Organ Failure Assessment (SOFA) score | A score that measures the amount of organ failure. Range 0-24, increasing score = worse organ failure. | Data only collected for Intensive care patients arm for this baseline measure. | Median | Inter-Quartile Range | units on a scale |
|
| Duration of invasive mechanical ventilation | Only recorded for intensive care patients arm. | Baseline measure only recorded for intensive care patients arm. | Median | Inter-Quartile Range | days |
|
| Profession | Profession of clinician participant. Not recorded for intensive care unit patients. | Data not collected for Intensive care patients arm for this baseline measure. | Count of Participants | Participants |
|
| ICU experience | Amount of intensive care unit experience in years. Not recorded for intensive care unit patients. | Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this has been summarized with a different measure type and dispersion, therefore is reported as a separate variable. | Median | Inter-Quartile Range | Years |
|
| ICU experience of rehabilitation clinicians | Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians arms, but summarised as a different measure type and dispersion, therefore reported as a different baseline measure. | Mean | Standard Deviation | Years |
|
| Healthcare experience | Not recorded for intensive care unit patients. | Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this was summarized as a different measure type and dispersion, therefore this is displayed as a separate variable. | Median | Inter-Quartile Range | Years |
|
| Healthcare experience of rehabilitation clinicians | Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians, however this was summarized as a different measure type and dispersion, therefore this is represented as a different baseline measure. | Mean | Standard Deviation | Years |
|
|
|
| Primary | Number of Participants With Follow-up at 60 Days | Patient participant follow-up rate at 60 days. | Total number of participants in this participant group | Posted | Count of Participants | Participants | 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 | For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above. | Posted | Count of Participants | Participants | 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 | For each of the 40 patient participants, number of randomization surveys completed by the four groups described above. | Posted | Count of Participants | Participants | 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 | For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above. | Posted | Count of Participants | Participants | 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. | Number of participants for whom pre-morbid evaluation of comorbidities was attempted. | Posted | Count of Participants | Participants | 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. | Number of participants for whom pre-morbid evaluation of frailty was attempted. | Posted | Count of Participants | Participants | 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. | Number of participants for whom the pre-morbid measurement of physical function was attempted. | Posted | Count of Participants | Participants | 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. | Number of mobilization treatments where data was available for analysis. Please note the categories presented below are not mutually exclusive e.g. a decision whether to mobilize could have been made with a nurse and a doctor. Therefore, the sum of the categories will be greater than the overall number of participants analyzed. | Posted | Number | Treatment sessions | Through duration of ICU stay (average of 7 days). | Treatment sessions | Treatment sessions |
|
|
|
| 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. | Number of mobilization treatments where data was available for analysis | Posted | Number | Entire group where data available | Through duration of ICU stay (average of 7 days). | Entire group where data available | Entire group where data available |
|
|
|
| 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. | Number of reviews by a physiotherapist where patient was not mobilized and where data was available. i.e. the overall number of participants analyzed/denominator is actually the overall number of physiotherapist reviews. Please note the categories presented below are not mutually exclusive e.g. the decision not to mobilize could have been made with a nurse and a physiotherapist. Therefore, the sum of the categories exceeds with overall number of participants analyzed. | Posted | Number | Reviews | Through duration of intensive care stay (average 7 days) | Number of treatment reviews | Number of treatment reviews |
|
|
|
| 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. | Number of reviews by a physiotherapist where patient was not mobilized and where data was available. | Posted | Number | Whole group where data was available | Through duration of intensive care stay (average 7 days) | Whole group where data was available | Whole group where data was available |
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|
|
| Secondary | The Reason Why a Mobilisation Treatment Was Stopped | Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out. | Number of treatment sessions for whom data was available | Posted | Number | Treatments | Through duration of ICU stay (average of 7 days). | Treatment sessions | Treatment sessions |
|
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|
| Secondary | Number of Serious Adverse Events | Number of serious adverse events | Number of mobilization treatment sessions for whom data was available | Posted | Number | events | Through whole of study, an estimated 6 months | Treatment sessions | Treatment sessions |
|
|
|
| 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. | Number of treatment sessions | Posted | Number | events | Through duration of ICU stay (average of 7 days). | Treatment sessions | Treatment sessions |
|
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|
| 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. | Number of mobilization treatments where adverse event tool used and data available for how long it took to complete. | Posted | Number | Treatments | Through duration of ICU stay (average of 7 days). | Treatment sessions | Treatment sessions |
|
|
|
| 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. | Number of mobilization treatment sessions whilst receiving vasoactive drugs | Posted | Number | Treatments | Through duration of ICU stay (average of 7 days). | Treatment sessions | Treatment sessions |
|
|
|
| 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. | Number of clinicians who completed the survey | Posted | Number | Participants | Through second half of the study, an estimated 3 months |
|
|
|
| Secondary | Time to First Mobilisation Treatment | Number of days to first rehabilitation treatment | Number of participants with data available for this outcome. | Posted | Median | Inter-Quartile Range | Days | 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. | Number of patient participants with data available. | Posted | Median | Inter-Quartile Range | Days | Through duration of hospital stay (average of 22 days) |
|
|
|
| Secondary | Time to First Being Able to Stand. | Regardless of the assistance required. | Number of participants with data available. | Posted | Median | Inter-Quartile Range | Days | Through duration of hospital stay (average of 22 days). |
|
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|
| Secondary | Time to First Being Able to Walk. | Regardless of assistance required. | Number of participants with data available. | Posted | Median | Inter-Quartile Range | Days | Through duration of hospital stay (average of 22 days). |
|
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| Secondary | Intensive Care Unit Length of Stay. | Number of participants | Posted | Median | Inter-Quartile Range | Days | From admission to ICU discharge (an average of 7 days) |
|
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| Secondary | Hospital Length of Stay | Number of participants | Posted | Median | Inter-Quartile Range | Days | From admission to hospital discharge (average of 22 days) |
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| 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. | Number of participants with data available. | Posted | Median | Inter-Quartile Range | Score on a scale | 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. | Number of participants | Posted | Count of Participants | Participants | 60 days. |
|
|
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| 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. | Number of participants | Posted | Number | participants | 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. | Number of participants with data available | Posted | Median | Inter-Quartile Range | Units on a scale | 60 days. |
|
|
|
| 5 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Intensive Care Unit Clinicians | Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | ICU Rehabilitation Clinicians | Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Other / not stated |
|
| Physiotherapist |
|
| Title | Measurements |
|---|---|
|
| Senior doctor |
|
| Doctor in charge |
|
| Surgical team |
|
|
| Post-operative |
|
| Rationale for chest optimisation and improve strength and function. |
|
| To assess strength and alertness |
|
| Surgical wound safe to mobilise / medically stable |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Blood pressure low and/or increasing/high vasoactive drug dose |
|
| Lack of staff |
|
| Pain |
|
| Did not give consent |
|
| Filter |
|
| Title | Measurements |
|---|---|
|
| Patient weakness/fatigue |
|
| Pain/discomfort |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Are the adverse events adequately defined? |
|
| Are the adverse events irrelevant or misleading? |
|
| Are the adverse events offensive or inappropriate? |
|
| Are adverse events unnecessary or repetitive? |
|
| Is the tool an appropriate length? |
|
| Measurements |
|---|
|
| Physical functioning - patient reported |
|
| Physical functioning - performance-based |
|