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NCT02524522 Clinical Trial

Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI

Mechanical Ventilation Complication Clinical Trial

— WEAN-IPI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02524522
Other study ID # WEAN-IPI
Secondary ID
Status Completed
Phase N/A
First received August 4, 2015
Last updated March 23, 2016
Start date August 2015
Est. completion date February 2016

Study information
Verified date March 2016
Source Northern State Medical University
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Russian Federation City hospital # 1 / Northern State Medical University, Arkhangelsk

Sponsors (1)
Lead Sponsor Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of postoperative mechanical ventilation Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs 24 hrs No
Secondary 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 No
Secondary 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 No
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