- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05847712
Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress - Part I
August 4, 2024 updated by: Glen P. Kenny, University of Ottawa
Safe Maximum Work Times and the Effectiveness of Work-rest Allocations in Mitigating Increases in Core Temperature During and on the Day Following Prolonged Moderate-intensity Work in the Heat in Young and Older Workers
Workplaces rely on upper heat stress limits provided by the American Conference of Governmental Industrial Hygienists (ACGIH) to manage the health and safety of workers in hot environments.
This is primarily achieved by interspersing work with rest periods, the length of which is dictated by environmental conditions and work intensity, to maintain core temperature at or below 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels).
However, these guidelines employ a "one size fits all" approach to exposure limits that does not consider individual variation between workers.
Moreover, they fail to provide direction on the safe, initial stay times before these heat-mitigation controls should be employed (i.e., rest breaks) in conditions exceeding upper heat stress limits.
While recent work has generated estimates of the initial stay times for young to older men before heat-mitigation controls are required for moderate-intensity work, this information is limited to a single work bout and does not consider a second work bout preceded by an extended rest period (e.g., lunch) or next day effects.
This is a key consideration, as prolonged work in the heat has been shown to cause next-day impairments in heat dissipation in older men.
Further, it remains unclear if the application of the prescribed ACGIH work-rest allocations thereafter would alleviate increases in core temperature for the duration of the work period (e.g., start of shift versus post-lunch period).
This project will address these knowledge gaps by determining if refinements in initial stay times for moderate-intensity work (represents the average work effort of physically demanding occupations) in the heat (26°C wet-bulb globe temperature) may be required for young and older adults for i) a second work bout that is preceded by an extended rest period such as a lunch break, and ii) a work bout performed on the next day.
This includes assessing the efficacy of the prescribed ACGIH work-rest allocations to mitigate increases in core temperature beyond safe limits (>38.0°C,
equivalent to a >1°C increase in body core temperature above resting levels) during these work periods.
Given the known sex-differences in heat loss that can modulate core temperature regulation during an exercise-heat stress, the investigators will conduct separate analysis to identify modulating effects of biological sex on the initial stay times and effectiveness of the work-rest allocation as a heat-alleviation control.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- young (18-30 years) and older adults (50-69 years)
- habitually active, not endurance trained (<2 sessions per week, <150 minutes per week)
- non-smoking
- English or French speaking
- ability to provide informed consent
Exclusion Criteria:
- pre-existing health conditions (e.g., diabetes, hypertension)
- use of medication deemed to significantly modulate thermoregulatory function and heat tolerance (e.g., antidepressants, antihistamines, diuretics)
- engaged in jobs and/or activities that involve frequent exposure to hot environments (e.g., regular sauna use)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Younger adults
Adults aged 18-30 years with no pre-existing health conditions
|
Participants perform a continuous moderate-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of ~240 min.
The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).
|
|
Experimental: Older adults
Adults aged 50-69 with no pre-existing health conditions
|
Participants perform a continuous moderate-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of ~240 min.
The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Initial stay time
Time Frame: End of first (morning day 1) continuous work bout
|
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
|
End of first (morning day 1) continuous work bout
|
|
Initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
|
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
|
End of second (afternoon day 1) continuous work bout
|
|
Initial stay time
Time Frame: End of third (morning day 2) continuous work bout
|
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
|
End of third (morning day 2) continuous work bout
|
|
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Average core temperature over final 2-hours of each work bout
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
|
Average core temperature following initial stay time
|
Period of work-rest allocations following initial stay time for afternoon day 1
|
|
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Average core temperature following initial stay time
|
Period of work-rest allocations following initial stay time for morning day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure
Time Frame: End of first (morning day 1) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of first (morning day 1) work period
|
|
Systolic blood pressure
Time Frame: End of second (afternoon day 1) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of second (afternoon day 1) work period
|
|
Systolic blood pressure
Time Frame: End of third (morning day 2) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of third (morning day 2) work period
|
|
Diastolic blood pressure
Time Frame: End of first (morning day 1) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of first (morning day 1) work period
|
|
Diastolic blood pressure
Time Frame: End of second (afternoon day 1) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of second (afternoon day 1) work period
|
|
Diastolic blood pressure
Time Frame: End of third (morning day 2) work period
|
Arterial blood pressure measured via automated oscillometry
|
End of third (morning day 2) work period
|
|
Mean arterial blood pressure
Time Frame: End of first (morning day 1) work period
|
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
|
End of first (morning day 1) work period
|
|
Mean arterial blood pressure
Time Frame: End of second (afternoon day 1) work period
|
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
|
End of second (afternoon day 1) work period
|
|
Mean arterial blood pressure
Time Frame: End of third (morning day 2) work period
|
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
|
End of third (morning day 2) work period
|
|
Rate pressure product
Time Frame: End of first (morning day 1) work period
|
Calculated as systolic blood pressure * heart rate
|
End of first (morning day 1) work period
|
|
Rate pressure product
Time Frame: End of second (afternoon day 1) work period
|
Calculated as systolic blood pressure * heart rate
|
End of second (afternoon day 1) work period
|
|
Rate pressure product
Time Frame: End of third (morning day 2) work period
|
Calculated as systolic blood pressure * heart rate
|
End of third (morning day 2) work period
|
|
Fluid consumption
Time Frame: End of first (morning day 1) work period
|
Cumulative fluid consumption calculated by weighing the participant's water intake
|
End of first (morning day 1) work period
|
|
Fluid consumption
Time Frame: End of second (afternoon day 1) work period
|
Cumulative fluid consumption calculated by weighing the participant's water intake
|
End of second (afternoon day 1) work period
|
|
Fluid consumption
Time Frame: End of third (morning day 2) work period
|
Cumulative fluid consumption calculated by weighing the participant's water intake
|
End of third (morning day 2) work period
|
|
Fluid loss
Time Frame: End of first (morning day 1) work period
|
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
|
End of first (morning day 1) work period
|
|
Fluid loss
Time Frame: End of second (afternoon day 1) work period
|
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
|
End of second (afternoon day 1) work period
|
|
Fluid loss
Time Frame: End of third (morning day 2) work period
|
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
|
End of third (morning day 2) work period
|
|
Change in plasma volume
Time Frame: End of first (morning day 1) work period
|
Determined from venous blood samples
|
End of first (morning day 1) work period
|
|
Change in plasma volume
Time Frame: End of second (afternoon day 1) work period
|
Determined from venous blood samples
|
End of second (afternoon day 1) work period
|
|
Change in plasma volume
Time Frame: End of third (morning day 2) work period
|
Determined from venous blood samples
|
End of third (morning day 2) work period
|
|
Thermal comfort scale
Time Frame: End of first (morning day 1) continuous work bout
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
End of first (morning day 1) continuous work bout
|
|
Thermal comfort scale
Time Frame: End of second (afternoon day 1) continuous work bout
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
End of second (afternoon day 1) continuous work bout
|
|
Thermal comfort scale
Time Frame: End of third (morning day 2) continuous work bout
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
End of third (morning day 2) continuous work bout
|
|
Thirst sensation scale
Time Frame: End of first (morning day 1) continuous work bout
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
End of first (morning day 1) continuous work bout
|
|
Thirst sensation scale
Time Frame: End of second (afternoon day 1) continuous work bout
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
End of second (afternoon day 1) continuous work bout
|
|
Thirst sensation scale
Time Frame: End of third (morning day 2) continuous work bout
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
End of third (morning day 2) continuous work bout
|
|
Rating of Perceived Exertion
Time Frame: End of first (morning day 1) continuous work bout
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
End of first (morning day 1) continuous work bout
|
|
Rating of Perceived Exertion
Time Frame: End of second (afternoon day 1) continuous work bout
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
End of second (afternoon day 1) continuous work bout
|
|
Rating of Perceived Exertion
Time Frame: End of third (morning day 2) continuous work bout
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
End of third (morning day 2) continuous work bout
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of first (morning day 1) continuous work bout
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
End of first (morning day 1) continuous work bout
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of second (afternoon day 1) continuous work bout
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
End of second (afternoon day 1) continuous work bout
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of third (morning day 2) continuous work bout
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
End of third (morning day 2) continuous work bout
|
|
Heart rate at initial stay time
Time Frame: End of first (morning day 1) continuous work bout
|
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of first (morning day 1) continuous work bout
|
|
Heart rate at initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
|
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of second (afternoon day 1) continuous work bout
|
|
Heart rate at initial stay time
Time Frame: End of third (morning day 2) continuous work bout
|
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of third (morning day 2) continuous work bout
|
|
Skin temperature at initial stay time
Time Frame: End of first (morning day 1) continuous work bout
|
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of first (morning day 1) continuous work bout
|
|
Skin temperature at initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
|
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of second (afternoon day 1) continuous work bout
|
|
Skin temperature at initial stay time
Time Frame: End of third (morning day 2) continuous work bout
|
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
End of third (morning day 2) continuous work bout
|
|
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Average heart rate following initial stay time
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
|
Average heart rate following initial stay time
|
Period of work-rest allocations following initial stay time for afternoon day 1
|
|
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Average heart rate following initial stay time
|
Period of work-rest allocations following initial stay time for morning day 2
|
|
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Average skin temperatures following initial stay time
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
|
Average skin temperatures following initial stay time
|
Period of work-rest allocations following initial stay time for afternoon day 1
|
|
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Average skin temperatures following initial stay time
|
Period of work-rest allocations following initial stay time for morning day 2
|
|
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
Period of work-rest allocations following initial stay time for afternoon day 1
|
|
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
|
Period of work-rest allocations following initial stay time for morning day 2
|
|
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 2
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
Period of work-rest allocations following initial stay time for afternoon day 2
|
|
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
Period of work-rest allocations following initial stay time for morning day 2
|
|
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 2
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
Period of work-rest allocations following initial stay time for afternoon day 2
|
|
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
Period of work-rest allocations following initial stay time for morning day 2
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
Period of work-rest allocations following initial stay time for morning day 1
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
Period of work-rest allocations following initial stay time for afternoon day 1
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
|
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance.
All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
|
Period of work-rest allocations following initial stay time for morning day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glen P Kenny, PhD, University of Ottawa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2023
Primary Completion (Actual)
July 12, 2024
Study Completion (Actual)
July 12, 2024
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
May 5, 2023
First Posted (Actual)
May 8, 2023
Study Record Updates
Last Update Posted (Actual)
August 6, 2024
Last Update Submitted That Met QC Criteria
August 4, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU 2023-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified participant data will be made available with approved analysis plan and signed access agreement
IPD Sharing Time Frame
Following publication of the main study report(s)
IPD Sharing Access Criteria
Approved analysis plan and signed access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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