NCT04548934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 2, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 2, 2020

Last Update Submit

February 1, 2021

Conditions

Cardiopulmonary ResuscitationPersonal Protective Equipment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Chest compression rate

    20 minutes of CPR

  • Relaxation

    20 minutes of CPR

Study Arms (2)

No PPE

ACTIVE COMPARATOR

Cardiopulmonary resuscitation without wearing personal protective equipment (PPE)

Device: No Personal protective equipment (PPE)

PPE

EXPERIMENTAL

Cardiopulmonary resuscitation while wearing personal protective equipment (PPE)

Device: Personal protective equipment (PPE)

Interventions

Personal protective equipment (PPE)DEVICE

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

PPE
No Personal protective equipment (PPE)DEVICE

Standard CPR without wearing PPE

No PPE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Headquarter of "Croce Bianca" EMS organization

Bolzano, 39100, Italy

Location

MeSH Terms

Interventions

Personal Protective Equipment

Intervention Hierarchy (Ancestors)

Protective DevicesEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Simon Rauch, MD, PhD

    Eurac research, Institute of mountain emergency medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 16, 2020

Study Start

September 13, 2020

Primary Completion

October 31, 2020

Study Completion

January 31, 2021

Last Updated

February 2, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)