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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01457651
Other study ID # RECR-CABG-2010
Secondary ID
Status Completed
Phase N/A
First received October 20, 2011
Last updated June 24, 2013
Start date March 2010
Est. completion date January 2012

Study information

Verified date June 2013
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

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation City hospital # 1 Arkhangelsk Arkhangelsk region

Sponsors (2)

Lead Sponsor Collaborator
Northern State Medical University Regional hospital of Arkhangelsk

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory support The duration of the postoperative respiratory support 24 hrs Yes
Secondary The incidence of postoperative atelectasis Incidence of atelectases during 24 hrs 24 hrs No
Secondary Incidence of reintubation 24 Hrs No
Secondary Oxygenation Changes in PaO2/FiO2 ratio 12 hrs after extubation No
Secondary Length of ICU and hospital stay Length of ICU and hospital stay 28 Days No
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