Facial Mask Ventilation in the Sars-CoV-2 pandemic scenario

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure; Respiratory Failure; SP4.001.012.143; CID 10 J98

• Registration Number: RBR-7xmbgsz
• Lead Sponsor: niversidade de Santa Cruz do Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study Completion: 2022-06-30
• Results First Posted: 2022-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with or without suspicion or confirmation of infection by SARS-CoV-2, of both sexes and aged between 18 and 90 years in acute respiratory failure (ARF)and with indication for the institution of non-invasive ventilation.
- Patients with exacerbation of chronic obstructive pulmonary disease (GOLD IV) with hypercapnic ARF with or without suspicion or confirmation of SARS-CoV-2 infection.
- Patients with congestive heart failure (NYHA 4) with or without suspected or confirmed SARS-CoV-2 infection.

Exclusion Criteria

- Comatose patients (Glasgow Coma Scale <8) or unable to protect the airways.
- Patients who refuse to receive non-invasive ventilation.
- Presence of facial anomalies, facial trauma and facial burn.
- Presentation of vomiting and severe hematemesis.
- Massive hemoptysis.
- Hemodynamically unstable patients (systolic blood pressure <80 mmHg) or receiving vasopressors / inotropes: ongoing angina / acute myocardial infarction or recently developed arrhythmia with hemodynamic impact.
- Patients undergoing recent esophageal or upper respiratory tract surgery (=2 weeks).
- Cardiorespiratory arrest.
- Patients or legal guardian who does not sign the informed consent form.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Such a primary outcome will be assessed by the number of patients involved in the research who underwent orotracheal intubation until the end of the study.