NCT01457651

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

October 20, 2011

Last Update Submit

June 24, 2013

Conditions

Keywords

RecruitmentCoronary artery bypass graftingPostoperative period

Outcome Measures

Primary Outcomes (1)

  • Respiratory support

    The duration of the postoperative respiratory support

    24 hrs

Secondary Outcomes (4)

  • The incidence of postoperative atelectasis

    24 hrs

  • Incidence of reintubation

    24 Hrs

  • Oxygenation

    12 hrs after extubation

  • Length of ICU and hospital stay

    28 Days

Study Arms (4)

Recruitment 40x40

ACTIVE COMPARATOR

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

Procedure: Alveolar recruitment

Recruitment PEAK40

ACTIVE COMPARATOR

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

Procedure: Alveolar recruitment

Recruitment 15x300

ACTIVE COMPARATOR

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

Procedure: Alveolar recruitment

No recruitment

ACTIVE COMPARATOR

No recruitment is performed: standard respiratory support.

Procedure: Alveolar recruitment

Interventions

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)

Also known as: CPAP40, PEAK40, PEEP15, CONTROLS
No recruitmentRecruitment 15x300Recruitment 40x40Recruitment PEAK40

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75
  • Off-pump coronary artery bypass grafting
  • Possibility to discontinue respiratory support in the first day after intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City hospital # 1

Arkhangelsk, Arkhangelskaya oblast, 163000, Russia

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mikhail Y. Kirov, MD, PhD

    Northern State Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 24, 2011

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations