Clinical trial NCT04548934: Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic
Official title: Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Personal Protective Equipment
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depth of chest compression
timeFrame: 20 minutes of CPR
Secondary outcomes:
measure: Chest compression rate
timeFrame: 20 minutes of CPR
measure: Relaxation
timeFrame: 20 minutes of CPR
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Headquarter of "Croce Bianca" EMS organization
Study officials:
affiliation: Eurac research, Institute of mountain emergency medicine
name: Simon Rauch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: