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

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

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.

Study Overview

• Status: Completed
• Conditions: Recruitment; Hypoxemia
• Intervention / Treatment: Procedure: Alveolar recruitment

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk region
    • Arkhangelsk, Arkhangelsk region, Russian Federation, 163000
      • City hospital # 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Recruitment 40x40; The group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds	Procedure: Alveolar recruitment; Four approaches: CPAP 40 cm H2O; Peak pressure 40 cm H2O; PEEP 15 cm H2O for 300 sec; no intervention (controls); Other Names: CPAP40; PEAK40; PEEP15; CONTROLS
Active Comparator: Recruitment PEAK40; Increase in peak airway pressure up to 40 cm H2O during tidal ventilation	Procedure: Alveolar recruitment; Four approaches: CPAP 40 cm H2O; Peak pressure 40 cm H2O; PEEP 15 cm H2O for 300 sec; no intervention (controls); Other Names: CPAP40; PEAK40; PEEP15; CONTROLS
Active Comparator: Recruitment 15x300; Recruitment by increase in airway PEEP up to 15 cm H2O for 300 sec	Procedure: Alveolar recruitment; Four approaches: CPAP 40 cm H2O; Peak pressure 40 cm H2O; PEEP 15 cm H2O for 300 sec; no intervention (controls); Other Names: CPAP40; PEAK40; PEEP15; CONTROLS
Active Comparator: No recruitment; No recruitment is performed: standard respiratory support.	Procedure: Alveolar recruitment; Four approaches: CPAP 40 cm H2O; Peak pressure 40 cm H2O; PEEP 15 cm H2O for 300 sec; no intervention (controls); Other Names: CPAP40; PEAK40; PEEP15; CONTROLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory support	The duration of the postoperative respiratory support	24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative atelectasis	Incidence of atelectases during 24 hrs	24 hrs
Incidence of reintubation		24 Hrs
Oxygenation	Changes in PaO2/FiO2 ratio	12 hrs after extubation
Length of ICU and hospital stay	Length of ICU and hospital stay	28 Days

Collaborators and Investigators

• Sponsor: Northern State Medical University
• Collaborators: Regional hospital of Arkhangelsk
• Investigators: Study Director: Mikhail Y. Kirov, MD, PhD, Northern State Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Recruitment; Postoperative period; Coronary artery bypass grafting
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: RECR-CABG-2010