Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery

Hypoxemia Clinical Trial

— RECR-CABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457651
• Other study ID #: RECR-CABG-2010
• 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

• Hypoxemia
• Recruitment

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