Early Versus Late Use of Hi-VNI in Covid-19

COVID-19 Clinical Trial

Official title:

The Outcome of Early Use of High-velocity Nasal Insufflation in Acute Respiratory Failure Complicating Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05663138
• Other study ID #: Hi-VNI in covid 19 patients
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Aswan University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved oxygenation	Patients with early use of Hi-VNI had better improvement of oxygenation than those with late use of Hi-VNI	through the study completion, average 6 months