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Completed

NCT Number: NCT04548934

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

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.

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Key information

Conditions

Cardiopulmonary Resuscitation Personal Protective Equipment

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Headquarter of "Croce Bianca" EMS organization

Bolzano, 39100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personal protective equipment (PPE)

Device

Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown)

No Personal protective equipment (PPE)

Device

Standard CPR without wearing PPE

Primary outcomes

  1. Depth of chest compression

    Time frame: 20 minutes of CPR

    Difference in chest compression depth during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).

Secondary outcomes

  1. Chest compression rate

    Time frame: 20 minutes of CPR

    Difference in chest compression rate during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).

  2. Relaxation

    Time frame: 20 minutes of CPR

    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).

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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