Covid19COVID-NIVNCT04667923
Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome
An observational study of Covid19 and ARDS, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Non-invasive ventilation can allow to avoid intubation and improve outcomes in moderate-to-severe COVID-19-associated acute respiratory distress-syndrome (ARDS). Data on NIV parameters adjustment based on expanded respiratory and gas exchange monitoring in COVID-19 associated ARDS is limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Respiratory monitoring, Respiratory muscles ultrasound and Electro impedance tomography
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2020to 31 Aug 2021
- 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: patients with COVID-19-associated moderate-to-severe acute respiratory distress-syndrome
Who may be able to join
- at least one of the following criteria: fatigue, Patrick scale 5 points, SpO2<92% on standard oxygen therapy (<15 l/min) or continuous positive airway pressure (CPAP)-therapy with oxygen flow<15 l/min
Who cannot join
- pregnancy
- age less than 18 or more than 80 years
- life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg despite norepinephrine at a dose > 2 µg/kg/min
- primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumour metastases in lungs
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure)
- Glasgow cona score < 14
- inability to swallow
- upper airways obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome to Prevent Tracheal Intubation: the COVID-NIV Study
Non-invasive ventilation can allow to avoid intubation and improve outcomes in moderate-to-severe COVID-19-associated acute respiratory distress-syndrome (ARDS). Data on NIV parameters adjustment based on expanded respiratory and gas exchange monitoring in COVID-19 associated ARDS is limited. Appropriate adjustment of the inspiratory positive airway pressure (IPAP) set as a point of the balance between minimal work of breathing (minimum point of W.Patrick scale for assessment of the accessory respiratory muscles and minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory rate can decrease NIV failure in moderate-to-severe COVID-ARDS. The objective of the study is to evaluate the ability of non-invasive ventilation guided with expanded respiratory monitoring to decrease the intubation rate in in moderate-to-severe COVID-ARDS.
Read the detailed description
In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure.
The objective of the study is to evaluate the ability of non-invasive ventilation guided with expanded respiratory monitoring to decrease the intubation rate in in moderate-to-severe COVID-ARDS. Investigators will set IPAP as a point of the balance between minimal work of breathing (minimum point of W.Patrick scale for assessment of the accessory respiratory muscles, and minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory rate. Investigators will set expiratory pressure at 8-10 cm of water and the inspiratory oxygen fraction (FiO2) to reach oxygen saturation by pulse oximetry (SpO2) 95%. All gas exchange measurements will be set at IPAP level. For gas exchange assessment investigators will measure partial oxygen tension in the arterial blood (PaO2), partial carbon dioxide tension in arterial blood (PaCO2), end-tidal carbon dioxide tension (PetCO2), then will calculate PAO2/FiO2, alveolar dead space (Vd alv) and ventilatory ratio (VR). Investigators will measure expiratory tidal volume (VT), respiratory rate (RR), peak inspiratory flow (PIF) and inspiratory time at 3 levels: at the set IPAP, at IPAP+4 cm of water and at IPAP-4 cm of water. Measurements will be repeated on day 1, 3, 5, 7, 14 and 21 of NIV. NIV failure is determined as one of the following at set IPAP 26 cm of water and FiO2 100%: fatigue, Patrick scale 5 points, SpO2<92%, apnoea, hemodynamic instability or Glasgow coma score <14 points.
In patients with NIV failure after intubation and every 7 day after intubation investigators will measure plateau pressure and calculate the driving pressure at PEEP 8-10-12-14 cm of water and VT 6 ml/kg predicted body weight (PBW), and VT+100 ml and VT+200 ml at PEEP 8 cm of water, plot static pressure volume-curve at positive end-expiratory pressure (PEEP) 5 and 14 cm of water, and perform electro impedance tomography.
This study is an observational trial in the ICU of the University hospital.
- Being tested
- Respiratory monitoring, Respiratory muscles ultrasound, Electro impedance tomography, Capnography, Arterial blood gas
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory monitoringDiagnostic test
Measurement of the tidal volume, peak inspiratory flow, inspiratory time, respiratory rate and the pressure gap during triggering on NIV and plateau pressure on mechanical ventilation
Respiratory muscles ultrasoundDiagnostic test
Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles
Electro impedance tomographyDiagnostic test
Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants
CapnographyDiagnostic test
Measurement of end-tidal carbon dioxide tension
Arterial blood gasDiagnostic test
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
Quasistatic pressure-volume curveDiagnostic test
Quasistatic pressure-volume curve
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Frequency of NIV failure
Measured: On day 28
Mortality
Mortality on day 28
Measured: On day 28
Secondary outcomes (5)
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement
Measured: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in ventilatory ratio
Measurement of arterial carbon dioxide tension, minute ventilation and calculation of ventilatory ratio
Measured: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in alveolar dead space
Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement
Measured: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in tidal volume
Measurement of exhaled tidal volume
Measured: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in accessory respiratory muscles workload
Calculation of the Patrick's scale (minimum 0 points, maximum 5 points, more points means worse outcome)
Measured: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey I Yaroshetskiy, MD, PhD, ScD, Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667923
- Sponsor's protocol ID
- 002-NIV-COVID
- Acronym
- COVID-NIV
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1.
PubMed 33067061Agarwal R, Handa A, Aggarwal AN, Gupta D, Behera D. Outcomes of noninvasive ventilation in acute hypoxemic respiratory failure in a respiratory intensive care unit in north India. Respir Care. 2009 Dec;54(12):1679-87.
PubMed 19961634Yaroshetskiy AI, Avdeev SN, Konanykhin VD. Acute Respiratory Distress Syndrome in COVID-19: Do All These Patients Definitely Require Intubation and Mechanical Ventilation? Am J Respir Crit Care Med. 2020 Nov 15;202(10):1480-1481. doi: 10.1164/rccm.202007-2713LE. No abstract available.
PubMed 32809841Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.
PubMed 8630538Yaroshetskiy AI, Merzhoeva ZM, Tsareva NA, Trushenko NV, Nuralieva GS, Konanykhin VD, Krasnoshchekova AP, Avdeev SN. Breathing pattern, accessory respiratory muscles work, and gas exchange evaluation for prediction of NIV failure in moderate-to-severe COVID-19-associated ARDS after deterioration of respiratory failure outside ICU: the COVID-NIV observational study. BMC Anesthesiol. 2022 Oct 1;22(1):307. doi: 10.1186/s12871-022-01847-7.
PubMed 36183064
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome to Prevent Tracheal Intubation: the COVID-NIV Study
- ClinicalTrials.gov ID
- NCT04667923
- Acronym / sponsor ID
- COVID-NIV / 002-NIV-COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Dec 2020 (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.
Non-invasive ventilation can allow to avoid intubation and improve outcomes in moderate-to-severe COVID-19-associated acute respiratory distress-syndrome (ARDS). Data on NIV parameters adjustment based on expanded respiratory and gas exchange monitoring in COVID-19 associated ARDS is limited. Appropriate adjustment of the inspiratory positive airway pressure (IPAP) set as a point of the balance between minimal work of breathing (minimum point of W.Patrick scale for assessment of the accessory respiratory muscles and minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory rate can decrease NIV failure in moderate-to-severe COVID-ARDS. The objective of the study is to evaluate the ability of non-invasive ventilation guided with expanded respiratory monitoring to decrease the intubation rate in in moderate-to-severe COVID-ARDS.
Detailed description
In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure.
The objective of the study is to evaluate the ability of non-invasive ventilation guided with expanded respiratory monitoring to decrease the intubation rate in in moderate-to-severe COVID-ARDS. Investigators will set IPAP as a point of the balance between minimal work of breathing (minimum point of W.Patrick scale for assessment of the accessory respiratory muscles, and minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory rate. Investigators will set expiratory pressure at 8-10 cm of water and the inspiratory oxygen fraction (FiO2) to reach oxygen saturation by pulse oximetry (SpO2) 95%. All gas exchange measurements will be set at IPAP level. For gas exchange assessment investigators will measure partial oxygen tension in the arterial blood (PaO2), partial carbon dioxide tension in arterial blood (PaCO2), end-tidal carbon dioxide tension (PetCO2), then will calculate PAO2/FiO2, alveolar dead space (Vd alv) and ventilatory ratio (VR). Investigators will measure expiratory tidal volume (VT), respiratory rate (RR), peak inspiratory flow (PIF) and inspiratory time at 3 levels: at the set IPAP, at IPAP+4 cm of water and at IPAP-4 cm of water. Measurements will be repeated on day 1, 3, 5, 7, 14 and 21 of NIV. NIV failure is determined as one of the following at set IPAP 26 cm of water and FiO2 100%: fatigue, Patrick scale 5 points, SpO2<92%, apnoea, hemodynamic instability or Glasgow coma score <14 points.
In patients with NIV failure after intubation and every 7 day after intubation investigators will measure plateau pressure and calculate the driving pressure at PEEP 8-10-12-14 cm of water and VT 6 ml/kg predicted body weight (PBW), and VT+100 ml and VT+200 ml at PEEP 8 cm of water, plot static pressure volume-curve at positive end-expiratory pressure (PEEP) 5 and 14 cm of water, and perform electro impedance tomography.
This study is an observational trial in the ICU of the University hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with COVID-19-associated moderate-to-severe acute respiratory distress-syndrome
Key inclusion criteria (1 listed)
- at least one of the following criteria: fatigue, Patrick scale 5 points, SpO2<92% on standard oxygen therapy (<15 l/min) or continuous positive airway pressure (CPAP)-therapy with oxygen flow<15 l/min
Key exclusion criteria (8 listed)
- pregnancy
- age less than 18 or more than 80 years
- life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg despite norepinephrine at a dose > 2 µg/kg/min
- primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumour metastases in lungs
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure)
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 |
|---|---|---|
| Respiratory monitoringMeasurement of the tidal volume, peak inspiratory flow, inspiratory time, respiratory rate and the pressure gap during triggering on NIV and plateau pressure on mechanical ventilation | Diagnostic test | – |
| Respiratory muscles ultrasoundMeasurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles | Diagnostic test | – |
| Electro impedance tomographyMeasurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants | Diagnostic test | – |
| CapnographyMeasurement of end-tidal carbon dioxide tension | Diagnostic test | – |
| Arterial blood gasMeasurement of the oxygen partial pressure and the carbon dioxide partial pressure | Diagnostic test | – |
| Quasistatic pressure-volume curveQuasistatic pressure-volume curve | Diagnostic test | – |
Primary outcome
Intubation rate
Time frame: On day 28
Frequency of NIV failure
Mortality
Time frame: On day 28
Mortality on day 28
5 secondary outcomes
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in ventilatory ratio
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in alveolar dead space
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in tidal volume
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Change in accessory respiratory muscles workload
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
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 Nov 2021.
- Background: PubMed 33067061Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1.
- Background: PubMed 19961634Agarwal R, Handa A, Aggarwal AN, Gupta D, Behera D. Outcomes of noninvasive ventilation in acute hypoxemic respiratory failure in a respiratory intensive care unit in north India. Respir Care. 2009 Dec;54(12):1679-87.
- Background: PubMed 32809841Yaroshetskiy AI, Avdeev SN, Konanykhin VD. Acute Respiratory Distress Syndrome in COVID-19: Do All These Patients Definitely Require Intubation and Mechanical Ventilation? Am J Respir Crit Care Med. 2020 Nov 15;202(10):1480-1481. doi: 10.1164/rccm.202007-2713LE. No abstract available.
- Background: PubMed 8630538Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.
- Derived from this study: PubMed 36183064Yaroshetskiy AI, Merzhoeva ZM, Tsareva NA, Trushenko NV, Nuralieva GS, Konanykhin VD, Krasnoshchekova AP, Avdeev SN. Breathing pattern, accessory respiratory muscles work, and gas exchange evaluation for prediction of NIV failure in moderate-to-severe COVID-19-associated ARDS after deterioration of respiratory failure outside ICU: the COVID-NIV observational study. BMC Anesthesiol. 2022 Oct 1;22(1):307. doi: 10.1186/s12871-022-01847-7.
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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.
Andrey I Yaroshetskiy, MD, PhD, ScD principal investigator
Sechenov 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 Covid19 and ARDS, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 8 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 Nov 2021. 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 Russia. 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?
Intubation rate (time frame: On day 28). The study lists 2 primary outcomes in all. 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 NCT04667923, which also lists 5 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 Nov 2021.