COVID-19 PneumoniaNCT05137431
High-flow Nasal Oxygenation and Non-invasive Ventilation Strategies for the Treatment of Covid-19 Pneumonia
An observational study of COVID-19 Pneumonia and COVID-19 Acute Respiratory Distress Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- HFNO and NIV
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2021to 30 Apr 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
- Adult, Older adult
Study population: This prospective, single-center study will be conducted in the Intensive Care Unit of Medipol Mega Hospital, an academic university hospital. It is planned to include patients over the age of 18 with a diagnosis of COVID 19 (severe respiratory failure and positive PCR test).
Who may be able to join
- PCR (+)
- P/F ≤300 mmHg (despite standard mask oxygen support from 15 L/min for 15 minutes)
- Respiratory rate ≥24/min or signs of respiratory failure (intercostal retraction, nasal wing breathing)
Who cannot join
- Chronic respiratory failure
- Cardiogenic pulmonary edema
- Aplasia
- GCS ≤12
- Hemodynamic instability (use of vasopressors)
- Emergency intubation requirement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: Comparison of High-flow Nasal Oxygenation and Non-invasive Ventilation Strategies for the Treatment of Covid-19 Pneumonia in the Intensive Care Unit: a Prospective Trial.
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.
Read the detailed description
Coronavirus 2019 disease (COVID-19) is a deadly infection that causes a new type of severe acute respiratory syndrome. It has been reported that the mortality rate in critically ill patients with a diagnosis of COVID-19 reached 61%. The primary pathology in these patients is progressive hypoxia due to lung injury and associated multi-organ damage. It has been reported that aggressive treatments such as tracheal intubation and classical mechanical ventilation to treat lung injury are not helpful or even harmful. The highest mortality rate was reported as 86% in these patients on mechanical ventilation. Acute respiratory distress syndrome (ARDS) developing in COVID-19 infection is not typical and is estimated to have a different mechanism, therefore it is emphasized that different strategies should be used for the treatment of ARDS in these patients. Two of the most important strategies used in these patients followed in the intensive care unit are high flow nasal oxygenation (High Flow Nasal Oxygenation-HFNO) and non-invasive ventilation (Non-Invasive Ventilation-NIV). HFNO is a method frequently used before intubation in adult patients with acute respiratory failure. It is based on the principle of giving warm and humidified oxygen to the patient through a nasal cannula in the range of 1-70 L/min. Due to the low number of mechanical ventilators in many intensive care units at the beginning of the pandemic, it was used in many COVID-19 patients and was found to be effective in later retrospective analyzes. It has been reported in many studies that HFNO therapy is more effective than conventional mask oxygen therapy. There are publications stating that it is more advantageous compared to NIV as it is easier to apply and more comfortable for the patient. Conventional NIV is called continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (BiPAP) ventilation. It is used as oxygen/ventilation therapy in SARS and H1N1 patients. Studies have reported that it is used in 70% of patients before tracheal intubation in COVID-19 patients. However, mortality was high in these patients.
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.
- Being tested
- HFNO and NIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNO and NIVOther
Patients meeting the inclusion criteria will be treated alternately with 2 hours of HFNO and 1 hour of NIV (HFNO-NIV for the same patient in turn). In 24 hours, there will be 16 hours of HFNO, 8 hours of NIV.
Parameters to record
- Respiratory parameters (respiratory rate)
- SpO2
- Ventilator settings
- Patient's tolerance (VAS; between 0-100)
- Arterial blood gas (HFNO and NIV at 1 hour)
- Clinical parameters (D dimer, CRP, ROX index)
Intubation criteria
- Loss of consciousness
- Agitation
- Persistent hypotension
- Need for fluid resuscitation
- Need for vasopressor
- Respiration rate ≥40/min
- SpO2 <92
- pH<7.30
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Oxygenation-HFNO | The current will be adjusted from 50-70 liters. The patient's SpO2 value will be maintained at at least 92%. Arterial blood gas will be checked at the 1st hour Receives: Other: HFNO and NIV | |
| Non-Invasive Ventilation-NIV | Tidal volume will be adjusted to be 6-8 ml/kg. The respiratory rate will be <30. The patient's SpO2 value will be maintained at at least 92%. The PEEP value will be 5 cmH2O. At the 1st hour, arterial blood gas will be checked. Receives: Other: HFNO and NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the treatment
The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation).
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start8 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 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-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137431
- Sponsor's protocol ID
- Medipol Hospital 22
- Status last verified
- Aug 2022
- First submitted
- 26 Nov 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
Calligaro GL, Lalla U, Audley G, Gina P, Miller MG, Mendelson M, Dlamini S, Wasserman S, Meintjes G, Peter J, Levin D, Dave JA, Ntusi N, Meier S, Little F, Moodley DL, Louw EH, Nortje A, Parker A, Taljaard JJ, Allwood BW, Dheda K, Koegelenberg CFN. The utility of high-flow nasal oxygen for severe COVID-19 pneumonia in a resource-constrained setting: A multi-centre prospective observational study. EClinicalMedicine. 2020 Nov;28:100570. doi: 10.1016/j.eclinm.2020.100570. Epub 2020 Oct 6.
PubMed 33043285Frat JP, Brugiere B, Ragot S, Chatellier D, Veinstein A, Goudet V, Coudroy R, Petitpas F, Robert R, Thille AW, Girault C. Sequential application of oxygen therapy via high-flow nasal cannula and noninvasive ventilation in acute respiratory failure: an observational pilot study. Respir Care. 2015 Feb;60(2):170-8. doi: 10.4187/respcare.03075. Epub 2014 Oct 7.
PubMed 25294935
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-flow Nasal Oxygenation and Non-invasive Ventilation Strategies for the Treatment of Covid-19 Pneumonia in the Intensive Care Unit: a Prospective Trial.
- ClinicalTrials.gov ID
- NCT05137431
- Acronym / sponsor ID
- Medipol Hospital 22
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Nov 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.
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.
Detailed description
Coronavirus 2019 disease (COVID-19) is a deadly infection that causes a new type of severe acute respiratory syndrome. It has been reported that the mortality rate in critically ill patients with a diagnosis of COVID-19 reached 61%. The primary pathology in these patients is progressive hypoxia due to lung injury and associated multi-organ damage. It has been reported that aggressive treatments such as tracheal intubation and classical mechanical ventilation to treat lung injury are not helpful or even harmful. The highest mortality rate was reported as 86% in these patients on mechanical ventilation. Acute respiratory distress syndrome (ARDS) developing in COVID-19 infection is not typical and is estimated to have a different mechanism, therefore it is emphasized that different strategies should be used for the treatment of ARDS in these patients. Two of the most important strategies used in these patients followed in the intensive care unit are high flow nasal oxygenation (High Flow Nasal Oxygenation-HFNO) and non-invasive ventilation (Non-Invasive Ventilation-NIV). HFNO is a method frequently used before intubation in adult patients with acute respiratory failure. It is based on the principle of giving warm and humidified oxygen to the patient through a nasal cannula in the range of 1-70 L/min. Due to the low number of mechanical ventilators in many intensive care units at the beginning of the pandemic, it was used in many COVID-19 patients and was found to be effective in later retrospective analyzes. It has been reported in many studies that HFNO therapy is more effective than conventional mask oxygen therapy. There are publications stating that it is more advantageous compared to NIV as it is easier to apply and more comfortable for the patient. Conventional NIV is called continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (BiPAP) ventilation. It is used as oxygen/ventilation therapy in SARS and H1N1 patients. Studies have reported that it is used in 70% of patients before tracheal intubation in COVID-19 patients. However, mortality was high in these patients.
HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Oxygenation-HFNO | – | Other: HFNO and NIVThe current will be adjusted from 50-70 liters. The patient's SpO2 value will be maintained at at least 92%. Arterial blood gas will be checked at the 1st hour |
| Non-Invasive Ventilation-NIV | – | Other: HFNO and NIVTidal volume will be adjusted to be 6-8 ml/kg. The respiratory rate will be <30. The patient's SpO2 value will be maintained at at least 92%. The PEEP value will be 5 cmH2O. At the 1st hour, arterial blood gas will be checked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This prospective, single-center study will be conducted in the Intensive Care Unit of Medipol Mega Hospital, an academic university hospital. It is planned to include patients over the age of 18 with a diagnosis of COVID 19 (severe respiratory failure and positive PCR test).
Key inclusion criteria (3 listed)
- PCR (+)
- P/F ≤300 mmHg (despite standard mask oxygen support from 15 L/min for 15 minutes)
- Respiratory rate ≥24/min or signs of respiratory failure (intercostal retraction, nasal wing breathing)
Key exclusion criteria (6 listed)
- Chronic respiratory failure
- Cardiogenic pulmonary edema
- Aplasia
- GCS ≤12
- Hemodynamic instability (use of vasopressors)
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 |
|---|---|---|
| HFNO and NIVPatients meeting the inclusion criteria will be treated alternately with 2 hours of HFNO and 1 hour of NIV (HFNO-NIV for the same patient in turn). In 24 hours, there will be 16 hours of HFNO, 8 hours of NIV. Parameters to record * Respiratory parameters (respiratory rate) * SpO2 * Ventilator settings * Patient's tolerance (VAS; between 0-100) * Arterial blood gas (HFNO and NIV at 1 hour) * Clinical parameters (D dimer, CRP, ROX index) Intubation criteria * Loss of consciousness * Agitation * Persistent hypotension * Need for fluid resuscitation * Need for vasopressor * Respiration rate ≥40/min * SpO2 <92 * pH<7.30 | Other | High Flow Nasal Oxygenation-HFNO, Non-Invasive Ventilation-NIV |
Primary outcome
Success of the treatment
Time frame: Through study completion, an average of 2 months
The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation).
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 11 Aug 2022.
- Background: PubMed 33043285Calligaro GL, Lalla U, Audley G, Gina P, Miller MG, Mendelson M, Dlamini S, Wasserman S, Meintjes G, Peter J, Levin D, Dave JA, Ntusi N, Meier S, Little F, Moodley DL, Louw EH, Nortje A, Parker A, Taljaard JJ, Allwood BW, Dheda K, Koegelenberg CFN. The utility of high-flow nasal oxygen for severe COVID-19 pneumonia in a resource-constrained setting: A multi-centre prospective observational study. EClinicalMedicine. 2020 Nov;28:100570. doi: 10.1016/j.eclinm.2020.100570. Epub 2020 Oct 6.
- Background: PubMed 25294935Frat JP, Brugiere B, Ragot S, Chatellier D, Veinstein A, Goudet V, Coudroy R, Petitpas F, Robert R, Thille AW, Girault C. Sequential application of oxygen therapy via high-flow nasal cannula and noninvasive ventilation in acute respiratory failure: an observational pilot study. Respir Care. 2015 Feb;60(2):170-8. doi: 10.4187/respcare.03075. Epub 2014 Oct 7.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pneumonia and COVID-19 Acute Respiratory Distress Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 11 Aug 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 Turkey (Türkiye). 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?
Success of the treatment (time frame: Through study completion, an average of 2 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 NCT05137431, 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 11 Aug 2022.