Acute Respiratory Failure
Conditions
Interventions
This is a randomized, unblinded clinical trial of a multicentric character, whose research center is the University of Santa Cruz do Sul (Santa Cruz do Sul - RS), with the Santa Cruz Hospital (HSC) as
E02.041.625.591
Sponsors
Universidade de Santa Cruz do Sul
Hospital Regional do Agreste Dr. Waldemiro Ferreira
Hospital Geral Otávio de Freitas (HGOF)
Santa Casa de Misericórdia de São Carlos (São Carlos - SP)
Hospital Ruth Cardoso
Hospital São Vicente de Paulo
Hospital de Aeronáutica de Canoas (HACO)
Hospital de Clínicas de Porto Alegre (HCPA)
Hospital de Caridade de Ijuí
Eligibility
Age
18 Months to 90 Months
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - In-hospital mortality [Period: up to 30 days]. Evaluated by the number of deaths that occurred within 30 days after the patient's involvement in the study. - Differences in RPaO2 / FiO2 in relation to the baseline values (before NIV) [Period: 48 h]. Calculated using the ratio between PaO2 and FiO2 displaced by arterial blood gases. - Improvement of RPaO2 / FiO2 after the beginning of NIV [Period: 1 h after NIV]. - PaCO2 levels [Period: 1 to 24 h after NIV]. Obtained by collecting arterial blood gases in 1 to 24 h after the initiation of NIV. - Blood pressure (BP) and increased hypotension (SBP <80 mmHg or mean arterial pressure <60 mmHg) [Period: up to 24 hours after NIV]. Measured by indirect and continuous blood pressure measurement. - Time between the beginning of NIV and its end (moment of resolution of respiratory failure). Measured through the time between the NIV institution and its end, - Time in the intensive care unit [time period: up to 30 days]. Measured by the number of days the patient stayed in the ICU. - Length of hospital stay of patients who used NIV. Measured by the number of days between admission and discharge from hospital or death. - Adverse effects of the mask: pressure ulcers, skin necrosis, air leak per mask, eye inflammation, gastric distention. Measured using the Questionnaire on acute adverse effects of the NIV mask. - Classification of patient comfort with the mask. Numerical rating scale ranging from 0 (light) to 10 (intense) (Visual analogue scale (VAS)) [Period: appear on pre-hospital discharge]. - Level of satisfaction after using NIV. Image through the Global Impression of Patient Change Questionnaire (PGIC). - NIV success rate with Owner mask or conventional orofacial mask. Success is defined as non-evolution to IOT [Deadline: 1 h since the beginning of NIV]. - Ventilatory variables: tidal volume (CV), minute volume (MV), peak pressure (Peak), FR, FiO2, inspiratory time (Ti), expiratory time (Te), air leakage (Leak), | — |
Countries
Brazil
Contacts
Public Contactdulciane paiva
Outcome results
None listed