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

June 24, 2013 updated by: Vsevolod V. Kuzkov, Northern State Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. CPAP 40 cm H2O
  2. Peak pressure 40 cm H2O
  3. PEEP 15 cm H2O for 300 sec
  4. 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:

  1. CPAP 40 cm H2O
  2. Peak pressure 40 cm H2O
  3. PEEP 15 cm H2O for 300 sec
  4. 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:

  1. CPAP 40 cm H2O
  2. Peak pressure 40 cm H2O
  3. PEEP 15 cm H2O for 300 sec
  4. 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:

  1. CPAP 40 cm H2O
  2. Peak pressure 40 cm H2O
  3. PEEP 15 cm H2O for 300 sec
  4. no intervention (controls)
Other Names:
  • CPAP40
  • PEAK40
  • PEEP15
  • CONTROLS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory support
Time Frame: 24 hrs
The duration of the postoperative respiratory support
24 hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of postoperative atelectasis
Time Frame: 24 hrs
Incidence of atelectases during 24 hrs
24 hrs
Incidence of reintubation
Time Frame: 24 Hrs
24 Hrs
Oxygenation
Time Frame: 12 hrs after extubation
Changes in PaO2/FiO2 ratio
12 hrs after extubation
Length of ICU and hospital stay
Time Frame: 28 Days
Length of ICU and hospital stay
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern State Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regional hospital of Arkhangelsk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mikhail Y. Kirov, MD, PhD, Northern State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECR-CABG-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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