Evidence map›Paper›PMID 35292837›Full record

Trial reportInternational orthopaedics2022

The use of a surgical helmet system with a high-efficiency particulate air filter as possible protection equipment during the coronavirus disease 2019 pandemic: a double-blinded randomized control study.

Giorgio Gasparini, Davide Castioni, Giovanna Spina, Filippo Familiari, Olimpio Galasso, Michele Mercurio

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International orthopaedics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Giorgio GaspariniDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Davide CastioniDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy. davide.n.castioni@gmail.com.ORCID http://orcid.org/0000-0003-3207-6651
Giovanna SpinaDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Filippo FamiliariDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Olimpio GalassoDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Michele MercurioDepartment of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Magna Graecia University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe rapid spread of coronavirus disease 2019 (COVID-19) has increased the use of personal protective equipment. The purpose of this study was to investigate whether a commercially available sterile surgical helmet system (SSHS) can be considered protective against COVID-19 and therefore safe for use.

methodsA double-blinded randomized controlled study was performed to investigate the efficacy of the ViVi® SSHS with a high-efficiency particulate air filter called HFD Hood (THI, Total Healthcare Innovation GmbH, Feistritz im Rosental, Austria) to protect against respiratory droplets. Forty recruited participants were divided into two different groups. The SSHS was tested using a validated qualitative test for respirator masks through saccharin or placebo solutions based on random allocation into two cohorts. Saccharin droplets are a validated surrogated marker for any elements of viral size, such as coronaviruses. A positive report of sweet taste after saccharin exposure was suggestive of ViVi® SSHS inefficacy in protection against droplets.

resultsOne participant out of 21 (4.8%) reported positive for taste within the placebo cohort, while five out of 19 (26.3%) reported positive for taste within the saccharin cohort upon testing. Two out of 21 (9.5%) participants reported positive for taste within the placebo cohort, and two out of 19 (10.5%) reported positive for taste within the saccharin cohort upon retesting. There were no statistically significant differences between the saccharin and placebo groups in either the test or retest measurements (p = 0.085 and p = 1.000, respectively).

conclusionsThis study demonstrates that the ViVi® SSHS equipped with HFD Hood protects against respiratory droplets, increasing protection against several microorganisms, including the virus that causes COVID-19, allowing surgeons to carry out procedures on COVID-positive patients in a more comfortable and safer way.

Indexed as

Air FiltersCOVID-19Head Protective DevicesHumansPandemicsSaccharinSARS-CoV-2SaccharinAerosol generating proceduresDropletsFilterPersonal protective equipmentSARS-CoV-2Surgical mask

Identifiers

PMID35292837
PMCPMC8923968
OpenAlexW4221070889

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.