Occupational health and safety among health care personnel in a COVID-19 pandemic

• Register: ISRCTN
• Last refreshed on: 27 April 2020
• Main ID: ISRCTN18348009
• Date of registration: 15/04/2020
• Prospective Registration: Yes
• Primary sponsor: University of Valladolid
• Public title: Occupational health and safety among health care personnel in a COVID-19 pandemic
• Scientific title: Predictive value of biological, physiological and analytical biomarkers with the use of personal protection equipment in COVID-19: observational, prospective, analytical, intervention and multicenter study
• Date of first enrolment: 16/04/2020
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18348009
• Study type: Observational
• Study design: Observational prospective cross-sectional cohort analytical intervention and multicenter study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Francisco Martín-Rodríguez

Key inclusion & exclusion criteria

Inclusion criteria:
1. Workers (doctors, nurses and assistants) in the COVID19 treatment unit with the biological risks training course
2. Aged over 18 years
3. Provide informed consent

Exclusion criteria:
1. Pregnant
2. Psychiatric pathology
3. Do not sign the informed consent
4. Not to be part of the HURH and Covid-Fair staff during the month of April


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Complications or secondary effects derived from the use of personal protective equipment against biological risks
Not Applicable

Intervention(s)

Volunteers (workers in a COVID19 treatment unit) undergo a structured and objective evaluation. Physiological variables (respiratory rate, saturation, heart rate, systolic and diastolic blood pressure and temperature) are collected, health variables are also collected (previous illnesses, taking medication, COVID19 symptoms, weight and height) and an analytical test is performed of blood (venous by extraction in the cephalic vein of the left arm) to obtain the following parameters: pH, PaCo2, PO2, HCO3, Na, K, Cl, Ca, Hematocrit, hemoglobin, lactate, glucose, urea, BUN and creatinine.

Volunteers are randomized, some wear N95 respirators and others wear an FFP2 mask with an exhalation valve, are fully equipped with personal protective equipment and enter the COVID19 area. At 4 hours of work they leave, are decontaminated and the same determinations that have been made on a basal basis are repeated. They are also asked if they have a headache (not due to the pressure of the glasses or face shield), wounds or chafing, and how they have felt at the level of tiredness.
At this time, the observation will end.

Primary Outcome(s)

1. Respiratory rate, assessed by clinical observation at baseline and at the end of the 4-hour workday
2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline and at the end of the 4-hour workday
3. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline and at the end of the 4-hour workday
4. Blood pressure, assessed using a Physio LifePAK® 15 monitor at the start of the study and at the end of the 4-hour workday
5. Tympanic temperature evaluated using a Braun ThermoScan® PRO 6000 model at baseline and at the end of the 4-hour workday
6. Weight, with the TANITA BC 545-N scale at baseline
8. Size, with the SECA 206 tape measure at baseline
9. Analytical biomarkers: pH, pCO2, pO2, cHCO3-, BE (ecf), cSO2, Na +, K +, Ca ++, Cl-, TCO2, Agap, AGapK, Hct, Hb, BE (b), Glu , Lac, BUN, Urea and Crea, evaluated using COPD Siemens Healthcare at baseline and at the end of the 4-hour workday
10. Medical history of interest, through a structured questionnaire at baseline
11. Level of physical activity using the IPAQ questionnaire at baseline

Secondary Outcome(s)

1. Headache presence measured using self-report at the end of the 4 hours of working with the equipment
2. Presence of serious adverse events during the use of protective equipment measured using self-report at the end of the 4 hours of working with the equipment
3. Presence of chafing, wounds, etc., due to the use of protective equipment measured using self-report at the end of the 4 hours of working with the equipment
4. Perception of the state of physical fatigue at the end of the working day with the protective equipment measured using self-report at the end of the 4 hours of working with the equipment
5. Time in COVID19 zone measured using self-report at the end of the 4 hours of working with the equipment

Secondary ID(s)

Nil known

V_01_2020_ref.03.v_02

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Approved 10/04/2020, CEIC Área de Salud de Valladolid Oeste (Hospital Universitario Río Hortega, 47012 Valladolid (Valladolid); [phone]; [e-mail]), ref: PI075-20

Results

• Date Completed: 22/04/2020