Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

Not Applicable

Completed

• Conditions: Postoperative Pulmonary Atelectasis; Mechanical Ventilation Complication
• Interventions: Device: SIMV mode; Device: INTELLiVENT-ASV mode

• Registration Number: NCT02524522
• Lead Sponsor: Northern State Medical University

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 .

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIMV mode	SIMV mode	Active comparator: Discontinuation from mechanical ventilation in postoperative period will be provided using physician driven protocol. The synchronized intermittent mandatory ventilation (SIMV) mode settings will be as follows: PEEP 5 cm of water, FiO2 to achieve SpO2 \> 94 %. Inspiratory pressure will be adjusted to deliver a tidal volume (VT) of 8 mL/kg predicted body weight; pressure support will be 2 cm of water higher. Respiratory rate (RR) will be adjusted to provide EtCO2 of 30-35 mm Hg. Respiratory rate and inspiratory pressure will be decreased gradually every 30 minutes. After decrease of inspiratory pressure to 6 cm of water (8 cm of water in case of BMI \> 30 kg/m2) and respiratory rate to 6/min, the spontaneous breathing trial (SBT) will be started.
INTELLiVENT-ASV mode	INTELLiVENT-ASV mode	Active comparator: Discontinuation of mechanical ventilation in postoperative period will be provided using automatically driven mode - INTELLiVENT-ASV. In the INTELLiVENT-ASV mode target EtCO2 will be 30-35 mm Hg, target SpO2 - 94-98%, quick wean option - activated.

Primary Outcome Measures

Name	Time	Method
Duration of postoperative mechanical ventilation	24 hrs	Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs

Secondary Outcome Measures

Name	Time	Method
Reduced incidence of postoperative respiratory complications	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.
Duration of intensive care unit stay	72 hours	Participants will be followed for the duration of the ICU stay, an expected average of 48 hrs

Trial Locations

Locations (1)

City hospital # 1 / Northern State Medical University,; 🇷🇺 Arkhangelsk, Russian Federation