Life-Saving Procedures Performed in the Pre-Decontamination Area While Wearing CBRNe Personal Protective Equipment: A Manikin Randomized Trial

This is a single-center, randomized (1:1), parallel-group, manikin trial comparing times of execution and quality of life-saving procedures performed by residents while wearing PPE for CBRNe events versus no PPE. The trial was deemed exempt from review by the local Ethics Committee (No. 0045954/2019). The study was conducted aiming to reduce carbon footprint and increase sustainability.

Study Population The trial involves Senior Emergency Medicine (EM) and Anesthesiology and Critical Care (ACC) residents (PGY-4 and -5) from the residency programs of the University of Padova (Padova, Italy), recruited via email by the study coordinator (GM) without selection. Eligible residents are certified as proficient at the procedures described in the next section by the respective residency board, being this a prerequisite to qualify as a PGY-4 and -5 in Italy. The subjects participating in the study don't receive any incentives. Written consent is asked prior to the beginning. The study is organized at the "SIMULARTI" medical simulation center of the University of Padova in Padova, Italy.

Interventions and Procedures Residents are involved in performing the following procedures on the ground on high fidelity manikins: two rescuers CPR (SUSIE - Gaumard Scientific, Miami, FL); tactical tourniquet application (with a Combat Application Tourniquet®, CAT Resources, Rock Hill, SC; on a Trauma Hal - Gaumard Scientific, Miami, FL); tension PNX needle decompression (Truman Trauma X - TruCorp, Lurgan, N. Ireland); positioning of peripheral venous access, intraosseous vascular access (with EZ-IO® - Teleflex, Wayne, PA), and drug preparation and administration (Code Blue III Adult - Gaumard Scientific, Miami, FL). Each procedure is accomplished by the algorithms collected in an operations manual made available to the researchers only, and verbally disclosed to the participants before their attempt (see Online Supplement 1). The participants do not receive any feedback, neither verbal nor visual, during the execution of the procedures. Subjects in the intervention group wear a Tyvek pro-tech® "C" gear (Bonetti, Milano, Italy), a full visor SGE 400 mask (EN 136:98 CL3) connected to an A2B2E2K2-P3 R filter (Spasciani, Milano, Italy), and well-fitting, non-sterile Mapa Ultranitril 480 gloves (Mapa SAS, Colombes, France). Subjects in the control group only wear well-fitting, medical examination nitrile gloves.

After the end of the procedures under investigation, participants from the control group are given the possibility to perform the procedures wearing CBRNe PPE, since this is a training session part of their curricular activities. Finally, an anonymous questionnaire was administered to the participants to evaluate their perception of the experience (Online Supplement 2). The questionnaire was composed of 10 items - 7 positive and 3 negative - that participants had to rate using a 5 point Likert scale (1=totally disagree; 2=disagree; 3=uncertain; 4=agree; 5=totally agree). The internal consistency of the questionnaire was measured using Cronbach's alfa.

Randomization For the 1:1 allocation of the residents, a computer-generated list of random numbers is used. Participants are randomly assigned following variable block sizes of 2 and 4 to either the intervention group (in which they wore CBRNe PPEs) or to a control group (in which they used only one pair of nitrile gloves) (Figure 1). Also, the participants perform each procedure in a random order according to a computer-generated sequence. Randomization is prepared by a researcher not directly involved with the experiments. The allocation of subjects and order of the procedures are concealed by using sequentially numbered, opaque, stapled envelopes, and upheld until each participant was in the simulation rooms. The experiment coordinator (MP) opens the envelopes and assigns participants to group and procedures. Blinding of participants and researchers involved in the experiment is unfortunately not possible. Only the outcome assessor and data analyst (SS) is kept blinded to the allocation.