Clinical trial NCT05663138: Early Versus Late Use of Hi-VNI in Covid-19
Official title: The Outcome of Early Use of High-velocity Nasal Insufflation in Acute Respiratory Failure Complicating Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Hi-VNI
Covid-19
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Aswan University
First posted: 2022-12-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as COVID-19 presented with respiratory failure and admitted to intensive care of COVID-19 zone, chest Department, Assiut University hospital, Patients who failed on either low flow nasal cannula or non-rebreathing mask were shifted to Hi-VNI device using a Precision flow vapotherm (vapotherm, Inc, 100 Domain device Exeter, NH 03833, T: 603-658-0011, USA). Patients were classified into 2 groups: Early and late Hi-VNI groups according to whether the shift to Hi-VNI occurred after low flow nasal cannula or non-rebreathing mask respectively.

Brief summary: This study evaluate early administration of high-velocity nasal insufflation in COVID-19 patients presented with acute respiratory failure after failure of conventional low flow nasal cannula bypassing the escalating step of Non re-breathing mask where early use of High velocity nasal insufflations achieved better improvement of respiratory distress, lower oxygen requirements and shorter ICU stay.

Detailed description: The study included 30 COVID-19 patients admitted to intensive care of COVID-19 zone, chest Department, quarantine section, Assiut University hospital. All patients were positive for COVID-19 infection by nasopharyngeal swab for detection of viral RNA by real time PCR for SAR-COV-2 RNA assay on 7500 Applied Bio-system. All patients received treatment based on the protocol of Egyptian Ministry of Health, Patients enrolled in the study were categorized into 2 groups, the 1st group included patients whom were shifted to Hi-VNI after failure of high flow nasal cannula, while the 2nd group included patients shifted to Hi-VNI after failure of non-rebreathing mask, using a Precision flow vapotherm (vapotherm, Inc, 100 Domain device Exeter, NH 03833, T: 603-658-0011, USA), that provide high velocity humidified flow through narrow bore nasl prongs

Eligibility criteria: Inclusion Criteria:

* 1-severe COVID Patients with hypoxemic respiratory failure. 2- Patients with no comorbidities

Exclusion Criteria:

1. Non severe COVID Patients
2. Patients with comorbidities (e.g chronic chest dis, DM, renal failure and hepatic failure
3. Patients indicated for mechanical ventilation
4. Patients with marked hypercapnia in need for non-invasive ventilation

Primary outcomes:
measure: Improved oxygenation
timeFrame: through the study completion, average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Fellow of Chest diseases Assiut University
name: Lamees M Bakkar, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Granton D, Chaudhuri D, Wang D, Einav S, Helviz Y, Mauri T, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson CL, Jaber S, Brochard L, Trivedi V, Ricard JD, Goligher EC, Burns KEA, Rochwerg B. High-Flow Nasal Cannula Compared With Conventional Oxygen Therapy or Noninvasive Ventilation Immediately Postextubation: A Systematic Review and Meta-Analysis. Crit Care Med. 2020 Nov;48(11):e1129-e1136. doi: 10.1097/CCM.0000000000004576.
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.