Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery

Conditions
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Respiratory Failure

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the first group: non-invasive mask ventilation<br>Dinamika of the indicator p/F Ratio | 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<br>* 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<br>|
| Experimental: the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)<br>Dinamika of the indicator p/F Ratio | 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<br>* 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<br>|
| Experimental: the third group:non-invasive ventilation with a helmet<br>Dinamika of the indicator p/F Ratio | 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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 more than 300 | Comparison of PaO2/FiO2 before/after research | hospitalisation period, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood oxygenation level | Comparison arterial blood oxygenation level before/after research | hospitalisation period, an average of 1 week | 
| maximum inspiratory volume | Comparison maximum inspiratory volume before/after research | hospitalisation period, an average of 1 week |