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Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery (RECR-CABG)

Primary Purpose

Hypoxemia, Recruitment

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Alveolar recruitment

About this trial

This is an interventional treatment trial for Hypoxemia focused on measuring Recruitment, Coronary artery bypass grafting, Postoperative period

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18 and 75
Off-pump coronary artery bypass grafting
Possibility to discontinue respiratory support in the first day after intervention

Exclusion Criteria:

Signs of ARDS
COPD in decompensation phase
Requirement for inotropic support(epinephrine >0,1 mcg/kg/hr)
Bronchiectases
Pregnancy
Morbid obesity
Aortic aneurism
AMI in previous month

Sites / Locations

City hospital # 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Recruitment 40x40

Recruitment PEAK40

Recruitment 15x300

No recruitment

Arm Description

The group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds

Increase in peak airway pressure up to 40 cm H2O during tidal ventilation

Recruitment by increase in airway PEEP up to 15 cm H2O for 300 sec

No recruitment is performed: standard respiratory support.

Outcomes

Primary Outcome Measures

Respiratory support

The duration of the postoperative respiratory support

Secondary Outcome Measures

The incidence of postoperative atelectasis

Incidence of atelectases during 24 hrs

Incidence of reintubation

Oxygenation

Changes in PaO2/FiO2 ratio

Length of ICU and hospital stay

Full Information

NCT ID

NCT01457651

First Posted

October 20, 2011

Last Updated

June 24, 2013

Sponsor

Northern State Medical University

Collaborators

Regional hospital of Arkhangelsk

1. Study Identification

Unique Protocol Identification Number

NCT01457651

Brief Title

Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery

Acronym

RECR-CABG

Official Title

Comparison of Different Types of Postoperative Pulmonary Recruitment and Predicting Its Efficacy Following Off-pump Coronary Artery Bypass Grafting

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northern State Medical University

Collaborators

Regional hospital of Arkhangelsk

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The risk of respiratory failure after cardiac surgery is high, and it may result in many complications. The maneuver of alveolar recruitment may improve the oxygen transport in the human organism. The investigators compare three different types of alveolar recruitment in patient after cardiac surgery, to reveal which one is better.

Detailed Description

The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxemia, Recruitment

Keywords

Recruitment, Coronary artery bypass grafting, Postoperative period

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recruitment 40x40

Arm Type

Active Comparator

Arm Description

The group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds

Arm Title

Recruitment PEAK40

Arm Type

Active Comparator

Arm Description

Increase in peak airway pressure up to 40 cm H2O during tidal ventilation

Arm Title

Recruitment 15x300

Arm Type

Active Comparator

Arm Description

Recruitment by increase in airway PEEP up to 15 cm H2O for 300 sec

Arm Title

No recruitment

Arm Type

Active Comparator

Arm Description

No recruitment is performed: standard respiratory support.

Intervention Type

Procedure

Intervention Name(s)

Alveolar recruitment

Other Intervention Name(s)

CPAP40, PEAK40, PEEP15, CONTROLS

Intervention Description

Four approaches: CPAP 40 cm H2O Peak pressure 40 cm H2O PEEP 15 cm H2O for 300 sec no intervention (controls)

Primary Outcome Measure Information:

Title

Respiratory support

Description

The duration of the postoperative respiratory support

Time Frame

24 hrs

Secondary Outcome Measure Information:

Title

The incidence of postoperative atelectasis

Description

Incidence of atelectases during 24 hrs

Time Frame

24 hrs

Title

Incidence of reintubation

Time Frame

24 Hrs

Title

Oxygenation

Description

Changes in PaO2/FiO2 ratio

Time Frame

12 hrs after extubation

Title

Length of ICU and hospital stay

Description

Length of ICU and hospital stay

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 and 75 Off-pump coronary artery bypass grafting Possibility to discontinue respiratory support in the first day after intervention Exclusion Criteria: Signs of ARDS COPD in decompensation phase Requirement for inotropic support(epinephrine >0,1 mcg/kg/hr) Bronchiectases Pregnancy Morbid obesity Aortic aneurism AMI in previous month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikhail Y. Kirov, MD, PhD

Organizational Affiliation

Northern State Medical University

Official's Role

Study Director

Facility Information:

Facility Name

City hospital # 1

City

Arkhangelsk

State/Province

Arkhangelsk region

ZIP/Postal Code

163000

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery

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