Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic

Cardiopulmonary Resuscitation Clinical Trial

Official title:

Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548934
• Other study ID #: CPR PPE
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Personal Protective Equipment

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