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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787666
• Other study ID #: 01092005
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: June 23, 2023

Study information

• Verified date: August 2023
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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
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

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Centre of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 more than 300	Comparison of PaO2/FiO2 before/after research	hospitalisation period, an average of 1 week
Secondary	arterial blood oxygenation level	Comparison arterial blood oxygenation level before/after research	hospitalisation period, an average of 1 week
Secondary	maximum inspiratory volume	Comparison maximum inspiratory volume before/after research	hospitalisation period, an average of 1 week

External Links

•   The article