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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
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
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Petrovsky Research National Centre of Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

the first group: non-invasive mask ventilation

the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)

the third group:non-invasive ventilation with a helmet

Arm Description

Dinamika of the indicator p/F Ratio

Dinamika of the indicator p/F Ratio

Dinamika of the indicator p/F Ratio

Outcomes

Primary Outcome Measures

PaO2/FiO2 more than 300
Comparison of PaO2/FiO2 before/after research

Secondary Outcome Measures

arterial blood oxygenation level
Comparison arterial blood oxygenation level before/after research
maximum inspiratory volume
Comparison maximum inspiratory volume before/after research

Full Information

First Posted
March 1, 2021
Last Updated
August 18, 2023
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04787666
Brief Title
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
Official Title
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the first group: non-invasive mask ventilation
Arm Type
Experimental
Arm Description
Dinamika of the indicator p/F Ratio
Arm Title
the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)
Arm Type
Experimental
Arm Description
Dinamika of the indicator p/F Ratio
Arm Title
the third group:non-invasive ventilation with a helmet
Arm Type
Experimental
Arm Description
Dinamika of the indicator p/F Ratio
Intervention Type
Procedure
Intervention Name(s)
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
Intervention Description
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
Primary Outcome Measure Information:
Title
PaO2/FiO2 more than 300
Description
Comparison of PaO2/FiO2 before/after research
Time Frame
hospitalisation period, an average of 1 week
Secondary Outcome Measure Information:
Title
arterial blood oxygenation level
Description
Comparison arterial blood oxygenation level before/after research
Time Frame
hospitalisation period, an average of 1 week
Title
maximum inspiratory volume
Description
Comparison maximum inspiratory volume before/after research
Time Frame
hospitalisation period, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander A. Eremenko, prof
Organizational Affiliation
Head of the Intensive Care Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Darya V. Ryabova
Organizational Affiliation
anesthesiologist-resuscitator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petrovsky Research National Centre of Surgery
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://intensive-care.ru/index.php/acc/article/view/433/2685
Description
The article

Learn more about this trial

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

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