NCT05663138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

December 20, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

Hi-VNICovid-19

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Early Hi-VNI

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

Late Hi-VNI

Group 2 of late use of Hi-VNI after NRM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related 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.

    PMID: 32947472BACKGROUND
  • 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.

    PMID: 27706464BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lamees M Bakkar, Fellow

    Fellow of Chest diseases Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

December 20, 2022

First Posted

December 23, 2022

Study Start

October 1, 2021

Primary Completion

February 28, 2022

Study Completion

March 15, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations