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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04787666

Enrollment

Registered

2021-03-08

Start date

2021-03-03

Completion date

2023-06-23

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief 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

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.

Interventions

PROCEDUREUsing 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026