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Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02524522
Acronym
WEAN-IPI
Enrollment
40
Registered
2015-08-14
Start date
2015-08-31
Completion date
2016-02-29
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Postoperative Pulmonary Atelectasis

Keywords

Integrated Pulmonary Index, automated protocol-driven weaning, pulmonary recruitment maneuver

Brief summary

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.

Detailed description

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 .

Interventions

DEVICEINTELLiVENT-ASV mode

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

DEVICESIMV mode

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

Sponsors

Northern State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative mechanical ventilation24 hrsParticipants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs

Secondary

MeasureTime frameDescription
Reduced incidence of postoperative respiratory complicationsup 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.
Duration of intensive care unit stay72 hoursParticipants will be followed for the duration of the ICU stay, an expected average of 48 hrs

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026