Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

NCT ID: NCT02524522

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

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 .

Conditions

Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

INTELLiVENT-ASV mode

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

SIMV mode

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Mikhail Y. Kirov

Professor, head of Anesthesiology dept.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikhail Y KIrov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern State Medical University

Locations

City hospital # 1 / Northern State Medical University,

Arkhangelsk, , Russia

Countries

Russia

Related Links

http://www.ccforum.com/content/17/5/R196

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

Other Identifiers

WEAN-IPI

Identifier Type: -

Identifier Source: org_study_id