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Compare helmet use during respirator use in patients with COVID

Comparison between the effectiveness of the Helmet interface through flow meters versus the mechanical fan for non-invasive ventilation in patients with Covid 19. Controlled and randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8gfdkg4
Enrollment
Unknown
Registered
2021-08-12
Start date
2021-09-24
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

COVID-19

Interventions

Patients of both sexes over 18 years old with COVID 19 and who agree to participate in the study will be evaluated. These will be randomized into two groups: one with Helmet plus NIV (non invasive ven
E02.041.625.591

Sponsors

Universidade Nove de Julho
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Individuals over the age of 18 years with type I respiratory failure with a suspected or confirmed diagnosis of pneumonia caused by COVID-19 who meet all of the following criteria: Adequate level of consciousness, In oxygen therapy with FiO2 ranging from 45% to 81%, with worsening oxygen flow. PaO2 / FIO2 <200 mmHg, PaCO2 equal to or less than 50 mmHg, Peripheral oxygen saturation (SpO2) <93% with an offer greater than 6 l/min, Relative contraindication of severe H; Hemodynamic stability

Exclusion criteria

Exclusion criteria: Patients who do not meet the inclusion criteria, who exhibit any absolute contraindication to the use of non-invasive mechanical ventilation and/or who exhibit the following conditions: Previous diagnosis of chronic obstructive pulmonary disease (COPD) with chronic CO2 retention or with its clinical characteristics according to the II Brazilian Consensus on Chronic Obstructive Pulmonary Disease of 2004, Tracheostomy, patients with proportional therapy criteria (palliatives), patients in circulatory shock, hypoxemia not related to viral pneumonia, patients with severe signs of hypoxemia: the central cyanosis; the lowered level of consciousness or severe psychomotor agitation; the FR > 35 and SpO2 < 80%.

Design outcomes

Primary

MeasureTime frame
It is expected that the use of NIV (Non-invasive mechanical ventilation) will reduce the length of stay by 30%.—

Secondary

MeasureTime frame
Borg Scale Reduction by 50%;Arterial blood gases are expected to remain at values ??between pH 7.35 and 7.45.;A 30% reduction in respiratory rate is expected.;Heart Rate is expected to remain at normal values ??between 70 to 90 bpm.—

Countries

Brazil

Contacts

Public ContactLuciana Malosá Sampaio
lucianamalosa@gmail.com+55 11 33859241

Outcome results

None listed

Source: REBEC (via WHO ICTRP)