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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2023-06-23

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

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the first group: non-invasive mask ventilation

Dinamika of the indicator p/F Ratio

Group Type EXPERIMENTAL

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

Intervention Type 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 for tackling the problem of respiratory failure

the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)

Dinamika of the indicator p/F Ratio

Group Type EXPERIMENTAL

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

Intervention Type 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 for tackling the problem of respiratory failure

the third group:non-invasive ventilation with a helmet

Dinamika of the indicator p/F Ratio

Group Type EXPERIMENTAL

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

Intervention Type 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 for tackling the problem of respiratory failure

Interventions

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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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age from 30 years to 60 years inclusive
2. Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
3. By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
4. Consent the patient to participate in this study

Exclusion Criteria

1. Tracheal intubation, absence of independent breathing
2. Unstable hemodynamics or hemodynamically significant rhythm disturbances
3. Acute violation of the cerebral blood supply
4. Shocks of various etiologies
5. Impossibility provide respiratory protection , high risk of aspiration
6. Lack of productive contact with the patient
7. Patient's refusal to participate in this study

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes