High Flow Nasal TherapyNCT05094648
High Flow Nasal Therapy in Covid 19 Patient
An observational study of High Flow Nasal Therapy, run by Maha Mahmoud Ahmed.
Trial summary
This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High Flow Nasal Therapy
- What is being tested?
- high flow nasal therapy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. demographic data including age, sex, smoking history, educational level. 2. Duration of illness before admission, clinical presentation, presence of co morbidities, BMI. 3. Vital signs, and radiologic findings 4. ABG at admission and (half an hour, 2hr, 24 hr, and 48hr)later on. 5. SPO2, FIO2, and respiratory rate at admission for calculating ROX index (SPO2/FIO2)/RR. 6. GCC, and APACHI score at time of admission. 7. Inflammatory markers at time of admission (CBC with differential, CRP, ferritin, D dimer, LDH), in addition to liver and renal function. At the end of the study patients will be claccifiedin to two groups based on success of high flow nasal therapy: Group A Covidpatient Who pass on high flow nasal therapy Group B Covidpatient who failed on nasal therapy and need NIV
Who may be able to join
- All Patients above 18 y old that will be diagnosed as COVID 19 based on PCR testing, who fulfil criteria that indicate need for high flow nasal therapy.
Who cannot join
- o Children less than 18 y old
- Oropharyngeal and Nasopharyngeal swap negative patients
- Patients who will refuse inclusion in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictors of Success of High Flow Nasal Therapy in Covid 19 Patients
This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients .
Read the detailed description
Coronavirus disease 2019 (COVID-19) is a potentially fatal infection caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)[1]. The highly contagious nature and exponential spread of SARS-CoV-2, coupled with its potential for a rapid progressto acute respiratory distress syndrome (ARDS), has overwhelmed health care systems globally, contributing to the high mortality rates in early reports [1,2].
The initial approach for respiratory support for severe COVID-19 pneumonia centredaround invasive mechanical ventilation and the standard lung protective strategy recommended for ARDS[3]. This may have been detrimental to a proportion of patients due to ventilator induced lung injury (VILI) and associated systemic inflammation[4]. Furthermore, other strategies to improve oxygenation may be more appropriate in patients with hypoxemic respiratory failure who do not require ventilatorysupport[4].
High-flow nasal oxygen (HFNO) is delivered by an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal interface.
It delivers adequately heated and humidified medical gas at flow-rates of up to 60L/min, and is considered to have a number of physiological benefits, including the reduction of anatomical dead space and work of breathing, the provision of a constant fraction of inspired oxygen with adequate humidification and a degree of positive end-expiratory pressure (PEEP) [5,6].
- Conditions
- High Flow Nasal Therapy
- Being tested
- high flow nasal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal therapyOther
effect of high flow nasal therapy in covid 19 patients who pass and who need non invasive
| Study group | Role | What they receive |
|---|---|---|
| group A | Covidpatient Who pass on high flow nasal therapy Receives: Other: high flow nasal therapy | |
| group B | Covidpatient who failed on high flow nasal therapy and need NIV Receives: Other: high flow nasal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of success of high flow nasal therapy in covid 19 patients
This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Flow Nasal TherapyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maha Mahmoud Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maha Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094648
- Sponsor's protocol ID
- nasal therapy in covid patient
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
PubMed 27016353
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Success of High Flow Nasal Therapy in Covid 19 Patients
- ClinicalTrials.gov ID
- NCT05094648
- Acronym / sponsor ID
- nasal therapy in covid patient
- Conditions
- High Flow Nasal Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maha Mahmoud AhmedUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Oct 2021 (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 aims to To identify factors that predict success of high flow nasal therapy in covid19 patients .
Detailed description
Coronavirus disease 2019 (COVID-19) is a potentially fatal infection caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)[1]. The highly contagious nature and exponential spread of SARS-CoV-2, coupled with its potential for a rapid progressto acute respiratory distress syndrome (ARDS), has overwhelmed health care systems globally, contributing to the high mortality rates in early reports [1,2].
The initial approach for respiratory support for severe COVID-19 pneumonia centredaround invasive mechanical ventilation and the standard lung protective strategy recommended for ARDS[3]. This may have been detrimental to a proportion of patients due to ventilator induced lung injury (VILI) and associated systemic inflammation[4]. Furthermore, other strategies to improve oxygenation may be more appropriate in patients with hypoxemic respiratory failure who do not require ventilatorysupport[4].
High-flow nasal oxygen (HFNO) is delivered by an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal interface.
It delivers adequately heated and humidified medical gas at flow-rates of up to 60L/min, and is considered to have a number of physiological benefits, including the reduction of anatomical dead space and work of breathing, the provision of a constant fraction of inspired oxygen with adequate humidification and a degree of positive end-expiratory pressure (PEEP) [5,6].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: high flow nasal therapyCovidpatient Who pass on high flow nasal therapy |
| group B | – | Other: high flow nasal therapyCovidpatient who failed on high flow nasal therapy and need NIV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. demographic data including age, sex, smoking history, educational level. 2. Duration of illness before admission, clinical presentation, presence of co morbidities, BMI. 3. Vital signs, and radiologic findings 4. ABG at admission and (half an hour, 2hr, 24 hr, and 48hr)later on. 5. SPO2, FIO2, and respiratory rate at admission for calculating ROX index (SPO2/FIO2)/RR. 6. GCC, and APACHI score at time of admission. 7. Inflammatory markers at time of admission (CBC with differential, CRP, ferritin, D dimer, LDH), in addition to liver and renal function. At the end of the study patients will be claccifiedin to two groups based on success of high flow nasal therapy: Group A Covidpatient Who pass on high flow nasal therapy Group B Covidpatient who failed on nasal therapy and need NIV
Key inclusion criteria (1 listed)
- All Patients above 18 y old that will be diagnosed as COVID 19 based on PCR testing, who fulfil criteria that indicate need for high flow nasal therapy.
Key exclusion criteria (3 listed)
- o Children less than 18 y old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal therapyeffect of high flow nasal therapy in covid 19 patients who pass and who need non invasive | Other | group A, group B |
Primary outcome
predictors of success of high flow nasal therapy in covid 19 patients
Time frame: Baseline
This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 27016353Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of High Flow Nasal Therapy, run by Maha Mahmoud Ahmed.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Mahmoud (01063453193, maha.mahmoud.1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of success of high flow nasal therapy in covid 19 patients (time frame: Baseline). 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 NCT05094648, which also lists 1 linked publication.
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 26 Oct 2021.