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Analysis and validation of leven67 emergency respirator

Analysis and validation of light mechanical emergency ventilation equipment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-7rgqkhf
Enrollment
Unknown
Registered
2021-01-15
Start date
2021-01-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus patients

Interventions

This is a survey, aiming to analyze and validate the LEVEN67 equipment for approval by ANVISA, aiming to meet or not the requirements considered as minimum and essential. To guarantee the safety of th
D012123

Sponsors

ASSOCIAÇÃO BENEFICENTE DE CAMPO GRANDE - Santa Casa de Campo Grande
Lead Sponsor
ASSOCIAÇÃO BENEFICENTE DE CAMPO GRANDE - Santa Casa de Campo Grande
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Adult patients aged 18 to 80 years; both sexes; adult patients with COVID-19; submitted to tracheal intubation; who await the availability of a conventional ventilator and / or a place in an ICU or Surgical Center bed; in need of tracheal intubation to protect the airways (such as traumatic brain injury); decompensated heart failure; severe pneumonia; without surgery for the next 6 (six) hours

Exclusion criteria

Exclusion criteria: patients under 18 and over 80; indigenous, patients with high doses of vasoactive drugs and hemodynamic instability; polytrauma patients with surgery expected in less than 6 hours; pregnant patients

Design outcomes

Primary

MeasureTime frame
It is expected to analyze and validate a new option of pulmonary ventilation, less prone to errors (since the use of ambu with the hands of professionals, can generate non-uniform and harmful ventilation). Thus, it is expected that this equipment can be a much safer solution for patients in the absence of a conventional pulmonary ventilator, in addition to being cheaper. The equipment is expected to behave 100% according to the bench and pig tests already analyzed and validated.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactTIAGO MOREIRA
torminato123@hotmail.com+55-67-999853581

Outcome results

None listed

Source: REBEC (via WHO ICTRP)