Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2023
CompletedAugust 22, 2023
August 1, 2023
2.3 years
March 1, 2021
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PaO2/FiO2 more than 300
Comparison of PaO2/FiO2 before/after research
hospitalisation period, an average of 1 week
Secondary Outcomes (2)
arterial blood oxygenation level
hospitalisation period, an average of 1 week
maximum inspiratory volume
hospitalisation period, an average of 1 week
Study Arms (3)
the first group: non-invasive mask ventilation
EXPERIMENTALDinamika of the indicator p/F Ratio
the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)
EXPERIMENTALDinamika of the indicator p/F Ratio
the third group:non-invasive ventilation with a helmet
EXPERIMENTALDinamika of the indicator p/F Ratio
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Petrovsky Research National Centre of Surgery
Moscow, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander A. Eremenko, prof
Head of the Intensive Care Unit
- PRINCIPAL INVESTIGATOR
Darya V. Ryabova
anesthesiologist-resuscitator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Russian national research center of surgery named after academian B. V. Petrovsky
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 8, 2021
Study Start
March 3, 2021
Primary Completion
June 23, 2023
Study Completion
June 23, 2023
Last Updated
August 22, 2023
Record last verified: 2023-08