Respiratory FailureNCT04787666
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
A study testing Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in people with Respiratory Failure, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 3 Mar 2021to 23 Jun 2023
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 30 years to 60 years inclusive
- Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
- By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
- Consent the patient to participate in this study
Who cannot join
- Tracheal intubation, absence of independent breathing
- Unstable hemodynamics or hemodynamically significant rhythm disturbances
- Acute violation of the cerebral blood supply
- Shocks of various etiologies
- Impossibility provide respiratory protection , high risk of aspiration
- Lack of productive contact with the patient
- Patient's refusal to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery
Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery
Read the detailed description
The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.
- Conditions
- Respiratory Failure
- Being tested
- Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmetProcedure or surgery
Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet for tackling the problem of respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| the first group: non-invasive mask ventilation | Experimental | Dinamika of the indicator p/F Ratio Receives: Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet |
| the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) | Experimental | Dinamika of the indicator p/F Ratio Receives: Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet |
| the third group:non-invasive ventilation with a helmet | Experimental | Dinamika of the indicator p/F Ratio Receives: Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 more than 300
Comparison of PaO2/FiO2 before/after research
Measured: hospitalisation period, an average of 1 week
Secondary outcomes (2)
arterial blood oxygenation level
Comparison arterial blood oxygenation level before/after research
Measured: hospitalisation period, an average of 1 week
maximum inspiratory volume
Comparison maximum inspiratory volume before/after research
Measured: hospitalisation period, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start3 Mar 2021
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darya Ryabova, research worker, Petrovsky National Research Centre of Surgery
- Investigators
- Alexander A. Eremenko, prof, Study director, Head of the Intensive Care UnitDarya V. Ryabova, Principal investigator, anesthesiologist-resuscitator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787666
- Sponsor's protocol ID
- 01092005
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04787666
- Acronym / sponsor ID
- 01092005
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 8 Mar 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.
Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery
Detailed description
The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the first group: non-invasive mask ventilation | Experimental | Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmetDinamika of the indicator p/F Ratio |
| the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) | Experimental | Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmetDinamika of the indicator p/F Ratio |
| the third group:non-invasive ventilation with a helmet | Experimental | Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmetDinamika of the indicator p/F Ratio |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 30 years to 60 years inclusive
- Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
- By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
- Consent the patient to participate in this study
Key exclusion criteria (7 listed)
- Tracheal intubation, absence of independent breathing
- Unstable hemodynamics or hemodynamically significant rhythm disturbances
- Acute violation of the cerebral blood supply
- Shocks of various etiologies
- Impossibility provide respiratory protection , high risk of aspiration
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 |
|---|---|---|
| Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmetUsing of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet for tackling the problem of respiratory failure | Procedure or surgery | the first group: non-invasive mask ventilation, the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation), the third group:non-invasive ventilation with a helmet |
Primary outcome
PaO2/FiO2 more than 300
Time frame: hospitalisation period, an average of 1 week
Comparison of PaO2/FiO2 before/after research
2 secondary outcomes
arterial blood oxygenation level
Time frame: hospitalisation period, an average of 1 week
maximum inspiratory volume
Time frame: hospitalisation period, an average of 1 week
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 22 Aug 2023.
- The articleLink provided by the sponsor.
Related trials for Respiratory Failure
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Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
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Mechanical Ventilator Adjustments and Patient Dyspnea
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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.
Alexander A. Eremenko, prof study director
Head of the Intensive Care Unit
Darya V. Ryabova principal investigator
anesthesiologist-resuscitator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in people with Respiratory Failure, run by Petrovsky National Research Centre of Surgery 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 7 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 22 Aug 2023. 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?
PaO2/FiO2 more than 300 (time frame: hospitalisation period, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.