COVID-19NCT05663138
Early Versus Late Use of Hi-VNI in Covid-19
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1-severe COVID Patients with hypoxemic respiratory failure. 2- Patients with no comorbidities
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of Early Use of High-velocity Nasal Insufflation in Acute Respiratory Failure Complicating Covid-19
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.
Read the 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
- Keywords
- Hi-VNI, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved oxygenation
Patients with early use of Hi-VNI had better improvement of oxygenation than those with late use of Hi-VNI
Measured: through the study completion, average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Oct 2021
- Primary completion28 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University
- Responsible party
- Principal investigator, Lamees Mohamed Bakkar, Assiut University
- Investigators
- Lamees M Bakkar, Fellow, Principal investigator, Fellow of Chest diseases Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663138
- Sponsor's protocol ID
- Hi-VNI in covid 19 patients
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32947472Hernandez 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.
PubMed 27706464
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Early Use of High-velocity Nasal Insufflation in Acute Respiratory Failure Complicating Covid-19
- ClinicalTrials.gov ID
- NCT05663138
- Acronym / sponsor ID
- Hi-VNI in covid 19 patients
- Conditions
- COVID-19
- Keywords
- Hi-VNI, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Aswan University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1-severe COVID Patients with hypoxemic respiratory failure. 2- Patients with no comorbidities
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improved oxygenation
Time frame: through the study completion, average 6 months
Patients with early use of Hi-VNI had better improvement of oxygenation than those with late use of Hi-VNI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 32947472Granton 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.
- Background: PubMed 27706464Hernandez 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.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamees M Bakkar, Fellow principal investigator
Fellow of Chest diseases Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved oxygenation (time frame: through the study completion, average 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.