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Completed

NCT Number: NCT02524522

Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

About this study

The outcome of elective off-pump coronary artery bypass grafting (OPCAB) can be significantly compromised due to early postoperative pulmonary complications. The risk of pulmonary complications including acute respiratory distress syndrome (ARDS), atelectases, and early ventilator-associated pneumonia remains inappropriate. Therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. Protocol-driven liberation from mechanical ventilation (CMV) can decrease the duration of CMV as well as the number of pulmonary complications. INTELLiVENT-Assisted spontaneous ventilation (INTELLiVENT-ASV) is a new approach, that may be as effective as conventional protocol-driven liberation from CMV.

In parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. One of the novel approaches to respiratory monitoring is Integrated Pulmonary Index (IPI). The Integrated Pulmonary Index merges four vital parameters including end-tidal carbon dioxide (EtCO2), respiratory rate, pulse rate, and oxygen saturation (SpO2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent.
  • Elective OPCAB.

Exclusion criteria

  • Participation in any other study.
  • Morbid obesity (BWI > 40).
  • The risk of pneumothorax after alveolar recruitment due to pulmonary emphysema.
  • Constant atrial fibrillation with pulse rate exceeding 100/min.
  • Inability to breathe easily through the nostrils and thus to gain good quality EtCO2 readings while breathing spontaneously, due to chronic rhinitis.

Treatment and study plan

INTELLiVENT-ASV mode

Device

Discontinuation with INTELLiVENT-ASV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided by quick-wean option of INTELLiVENT-ASV mode

SIMV mode

Device

Discontinuation with SIMV mode: discontinuation with SIMV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided in SIMV mode using physician driven algorithm

Primary outcomes

  1. Duration of postoperative mechanical ventilation

    Time frame: 24 hrs

    Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs

Secondary outcomes

  1. Reduced incidence of postoperative respiratory complications

    Time frame: up to 28 days postoperatively

    • Hypoxemia determined as partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) < 300 mm Hg.
    • Atelectases.
    • Nosocomial (ventilator-associated) pneumonia.
    • Hypoxemia determined as PaO2/FiO2 < 300 mm Hg.
    • Atelectases.
    • Nosocomial (ventilator-associated) pneumonia. Hypoxemia determined as PaO2/FiO2 < 300 mm Hg, atelectases, • Nosocomial (ventilator-associated) pneumonia.
  2. Duration of intensive care unit stay

    Time frame: 72 hours

    Participants will be followed for the duration of the ICU stay, an expected average of 48 hrs

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

Perioperative Pulmonary Recruitment and Postoperative Monitoring of Integrated Pulmonary Index in Off-pump Coronary Bypass Grafting

Acronym: WEAN-IPI

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Apr 6, 2016

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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