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

Petrovsky National Research Centre of Surgery

Status: Completed

Conditions: Respiratory Failure

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04787666

01092005

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

the first group: non-invasive mask ventilation

Experimental group

Description:

Dinamika of the indicator p/F Ratio

Treatment:

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 group

Description:

Dinamika of the indicator p/F Ratio

Treatment:

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 group

Description:

Dinamika of the indicator p/F Ratio

Treatment:

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