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Clinical Trials/NCT04787666
NCT04787666
Completed
Not Applicable

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

Petrovsky National Research Centre of Surgery1 site in 1 country90 target enrollmentMarch 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Petrovsky National Research Centre of Surgery
Enrollment
90
Locations
1
Primary Endpoint
PaO2/FiO2 more than 300
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2021
End Date
June 23, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Petrovsky National Research Centre of Surgery
Responsible Party
Principal Investigator
Principal Investigator

Darya Ryabova, research worker

Russian national research center of surgery named after academian B. V. Petrovsky

Petrovsky National Research Centre of Surgery

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

PaO2/FiO2 more than 300

Time Frame: hospitalisation period, an average of 1 week

Comparison of PaO2/FiO2 before/after research

Secondary Outcomes

  • maximum inspiratory volume(hospitalisation period, an average of 1 week)
  • arterial blood oxygenation level(hospitalisation period, an average of 1 week)

Study Sites (1)

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