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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: 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

• Registration Number: NCT04787666
• Lead Sponsor: Petrovsky National Research Centre of Surgery

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.

Study Timeline

• Study First Submitted: 2021-03-01
• Study Start: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-08
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the first group: non-invasive mask ventilation	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	Dinamika of the indicator p/F Ratio
the third group: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	Dinamika of the indicator p/F Ratio
the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)	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	Dinamika of the indicator p/F Ratio

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 more than 300	hospitalisation period, an average of 1 week	Comparison of PaO2/FiO2 before/after research

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Petrovsky Research National Centre of Surgery; 🇷🇺 Moscow, Russian Federation