Pneumonia, BacterialNCT06113432
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
A study testing Arterial blood gases, Respiratory rate (RR) and Pulseoximeter in people with Pneumonia, Bacterial and Respiratory Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial, Respiratory Failure, COVID-19 Pneumonia
- What is being tested?
- Arterial blood gases, Respiratory rate (RR) and Pulseoximeter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 19 Sep 2023to 30 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia or COVID-19
- The ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
- Respiratory rate more than > 25 per minute.
- Written informed consent
Who cannot join
- Patients who achieve the following target parameters with only low-flow oxygen therapy (flow up to 15 l/min): SpO2 > 93%, the patient does not have a subjective feeling of fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
- Unstable hemodynamics (systolic blood pressure <90 mm Hg or mean arterial pressure <65 mm Hg) and/or lactic acidosis (lactate >5 mmol/l and/or clinically diagnosed shock) and/or life-threatening arrhythmia,
- Metabolic acidosis (pH <7.30);
- Patients who were in the ICU for less than 24 hours for any reason
- Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
- Cardiogenic pulmonary edema,
Show all 14Show fewer
- Chronic diseases in the stag e of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
- Glasgow Coma Scale score <14 points,
- Swallowing disorders
- Hypercapnia (PaCO2>45 mmHg),
- The need for urgent tracheal intubation for any reason,
- Recent head surgery or anatomy that prevents the placement of a helmet or full face mask on the patient,
- Pregnancy,
- Inability to cooperate with staff
Trial locations and contacts
1 site in 1 country.
Russia1 site
City clinical hospital named after F.I.Inozemtsev, Moscow
Moscow, 105187
About this study
Official title: CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: a Comparative, Cross-over, Physiological Study
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
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. Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation.
The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI) (measuring esophageal pressure, transpulmonary pressure during inspiration and expiration), the patient's work of breathing (assessment of accessory muscles work) patient's comfort by visual-analog scale, gas exchange (by PaO2/FiO2 and Respiration Oxygenation Index (ROX-index), and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive pulmonary ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
- Being tested
- Arterial blood gases, Respiratory rate (RR), Pulseoximeter, Assessment of accessory respiratory muscles work, Esophageal pressure measurement
- Medical subject headings
- Pneumonia, Bacterial, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gasesDiagnostic test
Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Respiratory rate (RR)Diagnostic test
Measurement of respiratory rate by waveform analysis using a ventilator
PulseoximeterDiagnostic test
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
Assessment of accessory respiratory muscles workDiagnostic test
Patrick score calculation. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox.
Esophageal pressure measurementDiagnostic test
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
Discomfort Visual Analog Scale (VAS)Diagnostic test
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
Noninvasive blood pressureDiagnostic test
Noninvasive blood pressure
Heart rateDiagnostic test
Heart rate calculation using electrocardiogram monitoring
| Study group | Role | What they receive |
|---|---|---|
| Helmet-CPAP then Mask-CPAP | Experimental | CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes Receives: Diagnostic Test: Arterial blood gases; Diagnostic Test: Respiratory rate (RR); Diagnostic Test: Pulseoximeter; Diagnostic Test: Assessment of accessory respiratory muscles work; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Discomfort Visual Analog Scale (VAS); Diagnostic Test: Noninvasive blood pressure; Diagnostic Test: Heart rate |
| Mask-CPAP then Helmet-CPAP | Experimental | CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes Receives: Diagnostic Test: Arterial blood gases; Diagnostic Test: Respiratory rate (RR); Diagnostic Test: Pulseoximeter; Diagnostic Test: Assessment of accessory respiratory muscles work; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Discomfort Visual Analog Scale (VAS); Diagnostic Test: Noninvasive blood pressure; Diagnostic Test: Heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
Delta esophageal pressure
Measured: 40 minutes
Inspiratory delta transpulmonary pressure (stress)
Inspiratory delta transpulmonary pressure
Measured: 40 minutes
Expiratory delta transpulmonary pressure
Expiratory delta transpulmonary pressure
Measured: 40 minutes
Secondary outcomes (7)
Oxygenation
PaO2/FiO2 calculation
Measured: 40 minutes
Respiratory rate
Measurement of respiratory rate by waveform analysis using a ventilator
Measured: 40 minutes
ROX index
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
Measured: 40 minutes
Patrick's score
Patrick's score measurement, minimum 1point, maximum 5 points, higher score means worse outcome. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox.
Measured: 40 minutes
Discomfort visual analog scale (VAS)
Discomfort VAS score calculation, minimum 1point, maximum 10 points, higher score means better outcome
Measured: 40 minutes
Noninvasive blood pressure
Noninvasive blood pressure
Measured: 40 minutes
Heart rate
Heart rate calculation using electrocardiogram monitoring
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start19 Sep 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, BacterialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Enrolled patients will receive all types of respiratory support (helmet CPAP 40 minutes followed by full face mask CPAP 40 minutes or full face mask CPAP 40 minutes followed by helmet CPAP 40 minutes) in a randomized crossover design.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06113432
- Sponsor's protocol ID
- Helmet-Mask-ARF
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Care Med. 2002 Mar;30(3):602-8. doi: 10.1097/00003246-200203000-00019.
PubMed 11990923Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti A. Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study. Intensive Care Med. 2003 Oct;29(10):1680-7. doi: 10.1007/s00134-003-1931-8. Epub 2003 Aug 28.
PubMed 14564379Vargas F, Thille A, Lyazidi A, Campo FR, Brochard L. Helmet with specific settings versus facemask for noninvasive ventilation. Crit Care Med. 2009 Jun;37(6):1921-8. doi: 10.1097/CCM.0b013e31819fff93.
PubMed 19384209Chiumello D, Pelosi P, Carlesso E, Severgnini P, Aspesi M, Gamberoni C, Antonelli M, Conti G, Chiaranda M, Gattinoni L. Noninvasive positive pressure ventilation delivered by helmet vs. standard face mask. Intensive Care Med. 2003 Oct;29(10):1671-9. doi: 10.1007/s00134-003-1825-9. Epub 2003 Jun 12.
PubMed 12802491Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.
PubMed 30871304Saxena A, Nazir N, Pandey R, Gupta S. Comparison of Effect of Non-invasive Ventilation Delivered by Helmet vs Face Mask in Patients with COVID-19 Infection: A Randomized Control Study. Indian J Crit Care Med. 2022 Mar;26(3):282-287. doi: 10.5005/jp-journals-10071-24155.
PubMed 35519929Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.
PubMed 31687831
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: a Comparative, Cross-over, Physiological Study
- ClinicalTrials.gov ID
- NCT06113432
- Acronym / sponsor ID
- Helmet-Mask-ARF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Nov 2023 (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.
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
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. Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation.
The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI) (measuring esophageal pressure, transpulmonary pressure during inspiration and expiration), the patient's work of breathing (assessment of accessory muscles work) patient's comfort by visual-analog scale, gas exchange (by PaO2/FiO2 and Respiration Oxygenation Index (ROX-index), and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive pulmonary ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients will receive all types of respiratory support (helmet CPAP 40 minutes followed by full face mask CPAP 40 minutes or full face mask CPAP 40 minutes followed by helmet CPAP 40 minutes) in a randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Helmet-CPAP then Mask-CPAP | Experimental | Diagnostic Test: Arterial blood gases, Diagnostic Test: Respiratory rate (RR), Diagnostic Test: Pulseoximeter, Diagnostic Test: Assessment of accessory respiratory muscles work, Diagnostic Test: Esophageal pressure measurement, Diagnostic Test: Discomfort Visual Analog Scale (VAS), Diagnostic Test: Noninvasive blood pressure, Diagnostic Test: Heart rateCPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes |
| Mask-CPAP then Helmet-CPAP | Experimental | Diagnostic Test: Arterial blood gases, Diagnostic Test: Respiratory rate (RR), Diagnostic Test: Pulseoximeter, Diagnostic Test: Assessment of accessory respiratory muscles work, Diagnostic Test: Esophageal pressure measurement, Diagnostic Test: Discomfort Visual Analog Scale (VAS), Diagnostic Test: Noninvasive blood pressure, Diagnostic Test: Heart rateCPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia or COVID-19
- The ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
- Respiratory rate more than > 25 per minute.
- Written informed consent
Key exclusion criteria (14 listed)
- Patients who achieve the following target parameters with only low-flow oxygen therapy (flow up to 15 l/min): SpO2 > 93%, the patient does not have a subjective feeling of fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
- Unstable hemodynamics (systolic blood pressure <90 mm Hg or mean arterial pressure <65 mm Hg) and/or lactic acidosis (lactate >5 mmol/l and/or clinically diagnosed shock) and/or life-threatening arrhythmia,
- Metabolic acidosis (pH <7.30);
- Patients who were in the ICU for less than 24 hours for any reason
- Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
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 |
|---|---|---|
| Arterial blood gasesMeasurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Respiratory rate (RR)Measurement of respiratory rate by waveform analysis using a ventilator | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| PulseoximeterPeripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR) | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Assessment of accessory respiratory muscles workPatrick score calculation. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox. | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Esophageal pressure measurementEsophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Discomfort Visual Analog Scale (VAS)From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort. | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Noninvasive blood pressureNoninvasive blood pressure | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
| Heart rateHeart rate calculation using electrocardiogram monitoring | Diagnostic test | Helmet-CPAP then Mask-CPAP, Mask-CPAP then Helmet-CPAP |
Primary outcome
Inspiratory effort
Time frame: 40 minutes
Delta esophageal pressure
Inspiratory delta transpulmonary pressure (stress)
Time frame: 40 minutes
Inspiratory delta transpulmonary pressure
Expiratory delta transpulmonary pressure
Time frame: 40 minutes
Expiratory delta transpulmonary pressure
7 secondary outcomes
Oxygenation
Time frame: 40 minutes
Respiratory rate
Time frame: 40 minutes
ROX index
Time frame: 40 minutes
Patrick's score
Time frame: 40 minutes
Discomfort visual analog scale (VAS)
Time frame: 40 minutes
Noninvasive blood pressure
Time frame: 40 minutes
Heart rate
Time frame: 40 minutes
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 18 Jun 2024.
- Results publication: PubMed 11990923Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Care Med. 2002 Mar;30(3):602-8. doi: 10.1097/00003246-200203000-00019.
- Results publication: PubMed 14564379Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti A. Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study. Intensive Care Med. 2003 Oct;29(10):1680-7. doi: 10.1007/s00134-003-1931-8. Epub 2003 Aug 28.
- Results publication: PubMed 19384209Vargas F, Thille A, Lyazidi A, Campo FR, Brochard L. Helmet with specific settings versus facemask for noninvasive ventilation. Crit Care Med. 2009 Jun;37(6):1921-8. doi: 10.1097/CCM.0b013e31819fff93.
- Results publication: PubMed 12802491Chiumello D, Pelosi P, Carlesso E, Severgnini P, Aspesi M, Gamberoni C, Antonelli M, Conti G, Chiaranda M, Gattinoni L. Noninvasive positive pressure ventilation delivered by helmet vs. standard face mask. Intensive Care Med. 2003 Oct;29(10):1671-9. doi: 10.1007/s00134-003-1825-9. Epub 2003 Jun 12.
- Results publication: PubMed 30871304Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.
- Results publication: PubMed 35519929Saxena A, Nazir N, Pandey R, Gupta S. Comparison of Effect of Non-invasive Ventilation Delivered by Helmet vs Face Mask in Patients with COVID-19 Infection: A Randomized Control Study. Indian J Crit Care Med. 2022 Mar;26(3):282-287. doi: 10.5005/jp-journals-10071-24155.
- Results publication: PubMed 31687831Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.
- Individual participant dataSharing planned: No
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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?
A study testing Arterial blood gases, Respiratory rate (RR) and Pulseoximeter in people with Pneumonia, Bacterial and Respiratory Failure, 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 4 inclusion and 14 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 18 Jun 2024. 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?
Inspiratory effort (time frame: 40 minutes). The study lists 3 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 NCT06113432, which also lists 7 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 18 Jun 2024.