Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

NCT02524522 | Completed

• 1 other identifier: WEAN-IPI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative mechanical ventilation

  Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs

  24 hrs

Secondary Outcomes (2)

• Reduced incidence of postoperative respiratory complications

  up to 28 days postoperatively

• Duration of intensive care unit stay

  72 hours

Study Arms (2)

INTELLiVENT-ASV mode

ACTIVE COMPARATOR

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

SIMV mode

ACTIVE COMPARATOR

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

Interventions

INTELLiVENT-ASV mode 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

INTELLiVENT-ASV mode

SIMV mode 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

SIMV mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent.
• Elective OPCAB.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mikhail Y KIrov, MD, PhD

  Northern State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of Anesthesiology dept.

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)