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

Primary Purpose

Cardiopulmonary Resuscitation, Personal Protective Equipment

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Personal protective equipment (PPE)
No Personal protective equipment (PPE)
Sponsored by
Institute of Mountain Emergency Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Resuscitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Headquarter of "Croce Bianca" EMS organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No PPE

PPE

Arm Description

Cardiopulmonary resuscitation without wearing personal protective equipment (PPE)

Cardiopulmonary resuscitation while wearing personal protective equipment (PPE)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
September 2, 2020
Last Updated
February 1, 2021
Sponsor
Institute of Mountain Emergency Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04548934
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mountain Emergency Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Resuscitation, Personal Protective Equipment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No PPE
Arm Type
Active Comparator
Arm Description
Cardiopulmonary resuscitation without wearing personal protective equipment (PPE)
Arm Title
PPE
Arm Type
Experimental
Arm Description
Cardiopulmonary resuscitation while wearing personal protective equipment (PPE)
Intervention Type
Device
Intervention Name(s)
Personal protective equipment (PPE)
Intervention Description
Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown)
Intervention Type
Device
Intervention Name(s)
No Personal protective equipment (PPE)
Intervention Description
Standard CPR without wearing PPE
Primary Outcome Measure Information:
Title
Depth of chest compression
Description
Difference in chest compression depth during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).
Time Frame
20 minutes of CPR
Secondary Outcome Measure Information:
Title
Chest compression rate
Description
Difference in chest compression rate during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).
Time Frame
20 minutes of CPR
Title
Relaxation
Description
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).
Time Frame
20 minutes of CPR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Rauch, MD, PhD
Organizational Affiliation
Eurac research, Institute of mountain emergency medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headquarter of "Croce Bianca" EMS organization
City
Bolzano
ZIP/Postal Code
39100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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