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OpenTrials
Completed

NCT Number: NCT04787666

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

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petrovsky Research National Centre of Surgery

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 for tackling the problem of respiratory failure

Primary outcomes

  1. PaO2/FiO2 more than 300

    Time frame: hospitalisation period, an average of 1 week

    Comparison of PaO2/FiO2 before/after research

Secondary outcomes

  1. arterial blood oxygenation level

    Time frame: hospitalisation period, an average of 1 week

    Comparison arterial blood oxygenation level before/after research

  2. maximum inspiratory volume

    Time frame: hospitalisation period, an average of 1 week

    Comparison maximum inspiratory volume before/after research

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2021
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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