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

NCT ID: NCT05663138

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-03-15

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

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Early Hi-VNI

Group 1 of early shift to Hi-VNI after nasal cannula

No interventions assigned to this group

Late Hi-VNI

Group 2 of late use of Hi-VNI after NRM

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University

OTHER

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Lamees Mohamed Bakkar

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lamees M Bakkar, Fellow

Role: PRINCIPAL_INVESTIGATOR

Fellow of Chest diseases Assiut University

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32947472 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27706464 (View on PubMed)

Other Identifiers

Hi-VNI in covid 19 patients

Identifier Type: -

Identifier Source: org_study_id