Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI (WEAN-IPI)

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis
• Intervention / Treatment: Device: INTELLiVENT-ASV mode; Device: SIMV mode

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • City hospital # 1 / Northern State Medical University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: INTELLiVENT-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
Active Comparator: 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.	Device: SIMV 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative mechanical ventilation	Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs	24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced incidence of postoperative respiratory complications	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.	up to 28 days postoperatively
Duration of intensive care unit stay	Participants will be followed for the duration of the ICU stay, an expected average of 48 hrs	72 hours

Collaborators and Investigators

• Sponsor: Northern State Medical University

Publications and helpful links

Helpful Links

• Feasibility study on full closed-loop control ventilation (IntelliVent-ASV™) in ICU patients with acute respiratory failure: a prospective observational comparative study

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Integrated Pulmonary Index; automated protocol-driven weaning; pulmonary recruitment maneuver
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: WEAN-IPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO