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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548934
Other study ID # CPR PPE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2020
Est. completion date January 31, 2021

Study information

Verified date September 2020
Source Institute of Mountain Emergency Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background The significant risk of transmission of SARS-CoV-2 to healthcare staff mandated changes to Basic and Advanced Life Support (BLS and ALS) guidelines. As advised by the European Resuscitation Council (ERC), healthcare staff should put on airborne-precaution personal protective equipment (PPE) before starting chest compressions and/or airway interventions, as a minimum an FFP3 mask (FFP2 or N95 if FFP3 not available), eye and face protection and long-sleeved gown. However, wearing FFP3 masks has been shown to highly impair cardiopulmonary exercise capacity and the effect of wearing PPE on the quality of cardiopulmonary resuscitation is not known. The aim of this project is therefore to to investigate whether wearing PPE has an effect on the quality of chest compressions. Methods The study forsees a simulated CPR scenario on manikins. Study participants are lay rescuers and members of the rescue organization Croce Bianca. Each participant will perform 5 sequences consisting of 2 min of chest compressions altered by 2 min of no chest compressions (break), as recommended by the current ERC guidelines. The participants will perform the described CPR sequence two times in a cross-over design with randomized order, once while wearing PPE and once without wearing PPE. Between the two CPR sequences (i.e. with and without PPE) a break of 60 min for recovery will be given. During both CPR sequences, the quality of chest compressions will be measured.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 31, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Member of the rescue organization "Croce Bianca" - Aged 18-60 - Certified in basic life support (BLS) - No current COVID-19 symptoms, not being tested positive for COVID-19, no COVID-19 symptoms in the 4 weeks before the tests, no quarantine or unprotected contacts with COVID positive patients in the last 4 weeks, body temperature = 37.5°on test days. - Obtained informed consent. Exclusion Criteria: - Age <16 or >60 years, - No informed consent - Current COVID-19 symptoms, being tested positive for COVID 19 or symptoms in the 4 weeks before the tests, quarantine or unprotected contacts with COVID-19 positive patients in the last 4 weeks, body temperature = 37.5°on test days.

Study Design


Intervention

Device:
Personal protective equipment (PPE)
Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown)
No Personal protective equipment (PPE)
Standard CPR without wearing PPE

Locations

Country Name City State
Italy Headquarter of "Croce Bianca" EMS organization Bolzano

Sponsors (1)

Lead Sponsor Collaborator
Institute of Mountain Emergency Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depth of chest compression Difference in chest compression depth during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE). 20 minutes of CPR
Secondary Chest compression rate Difference in chest compression rate during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE). 20 minutes of CPR
Secondary Relaxation Difference in the percentage of compressions with incomplete release during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE). 20 minutes of CPR
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