Clinical trial NCT02524522: Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI
Official title: Perioperative Pulmonary Recruitment and Postoperative Monitoring of Integrated Pulmonary Index in Off-pump Coronary Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Postoperative Pulmonary Atelectasis
Keywords: Integrated Pulmonary Index
automated protocol-driven weaning
pulmonary recruitment maneuver
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of postoperative mechanical ventilation
timeFrame: 24 hrs
Secondary outcomes:
measure: Reduced incidence of postoperative respiratory complications
timeFrame: up to 28 days postoperatively
measure: Duration of intensive care unit stay
timeFrame: 72 hours
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: City hospital # 1 / Northern State Medical University,
Study officials:
affiliation: Northern State Medical University
name: Mikhail Y KIrov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: