Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery

NCT ID: NCT01457651

Last Updated: 2013-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-01-31

Brief Summary

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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

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

Conditions

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Hypoxemia Recruitment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Recruitment 40x40

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

Group Type ACTIVE_COMPARATOR

Alveolar recruitment

Intervention Type PROCEDURE

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)

Recruitment PEAK40

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

Group Type ACTIVE_COMPARATOR

Alveolar recruitment

Intervention Type PROCEDURE

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)

Recruitment 15x300

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

Group Type ACTIVE_COMPARATOR

Alveolar recruitment

Intervention Type PROCEDURE

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)

No recruitment

No recruitment is performed: standard respiratory support.

Group Type ACTIVE_COMPARATOR

Alveolar recruitment

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Other Intervention Names

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CPAP40 PEAK40 PEEP15 CONTROLS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional hospital of Arkhangelsk

UNKNOWN

Sponsor Role collaborator

Northern State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Vsevolod V. Kuzkov

Associate Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikhail Y. Kirov, MD, PhD

Role: STUDY_DIRECTOR

Northern State Medical University

Locations

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City hospital # 1

Arkhangelsk, Arkhangelskaya oblast, Russia

Site Status

Countries

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Russia

Other Identifiers

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RECR-CABG-2010

Identifier Type: -

Identifier Source: org_study_id

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