HypoxemiaRECR-CABGNCT01457651
Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery
A study testing Alveolar recruitment in people with Hypoxemia and Recruitment, run by Northern State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoxemia, Recruitment
- What is being tested?
- Alveolar recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75
- Off-pump coronary artery bypass grafting
- Possibility to discontinue respiratory support in the first day after intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.
- Conditions
- Hypoxemia, Recruitment
- Being tested
- Alveolar recruitment
- Keywords
- Recruitment, Coronary artery bypass grafting, Postoperative period
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitmentProcedure or surgery
Also called CPAP40, PEAK40, PEEP15, CONTROLS
Four approaches:
- CPAP 40 cm H2O
- Peak pressure 40 cm H2O
- PEEP 15 cm H2O for 300 sec
- no intervention (controls)
| Study group | Role | What they receive |
|---|---|---|
| Recruitment 40x40 | Active comparator | The group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds Receives: Procedure: Alveolar recruitment |
| Recruitment PEAK40 | Active comparator | Increase in peak airway pressure up to 40 cm H2O during tidal ventilation Receives: Procedure: Alveolar recruitment |
| Recruitment 15x300 | Active comparator | Recruitment by increase in airway PEEP up to 15 cm H2O for 300 sec Receives: Procedure: Alveolar recruitment |
| No recruitment | Active comparator | No recruitment is performed: standard respiratory support. Receives: Procedure: Alveolar recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory support
The duration of the postoperative respiratory support
Measured: 24 hrs
Secondary outcomes (4)
The incidence of postoperative atelectasis
Incidence of atelectases during 24 hrs
Measured: 24 hrs
Incidence of reintubation
Measured: 24 Hrs
Oxygenation
Changes in PaO2/FiO2 ratio
Measured: 12 hrs after extubation
Length of ICU and hospital stay
Length of ICU and hospital stay
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Regional hospital of Arkhangelsk
- Responsible party
- Principal investigator, Vsevolod V. Kuzkov, Northern State Medical University
- Investigators
- Mikhail Y. Kirov, MD, PhD, Study director, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457651
- Sponsor's protocol ID
- RECR-CABG-2010
- Acronym
- RECR-CABG
- Status last verified
- Jun 2013
- First submitted
- 20 Oct 2011
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Types of Postoperative Pulmonary Recruitment and Predicting Its Efficacy Following Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01457651
- Acronym / sponsor ID
- RECR-CABG / RECR-CABG-2010
- Conditions
- Hypoxemia, Recruitment
- Keywords
- Recruitment, Coronary artery bypass grafting, Postoperative period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Collaborators
- Regional hospital of Arkhangelsk
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recruitment 40x40 | Active comparator | Procedure: Alveolar recruitmentThe group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds |
| Recruitment PEAK40 | Active comparator | Procedure: Alveolar recruitmentIncrease in peak airway pressure up to 40 cm H2O during tidal ventilation |
| Recruitment 15x300 | Active comparator | Procedure: Alveolar recruitmentRecruitment by increase in airway PEEP up to 15 cm H2O for 300 sec |
| No recruitment | Active comparator | Procedure: Alveolar recruitmentNo recruitment is performed: standard respiratory support. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75
- Off-pump coronary artery bypass grafting
- Possibility to discontinue respiratory support in the first day after intervention
Key exclusion criteria (8 listed)
- Signs of ARDS
- COPD in decompensation phase
- Requirement for inotropic support(epinephrine >0,1 mcg/kg/hr)
- Bronchiectases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar recruitmentAlso: CPAP40, PEAK40, PEEP15, CONTROLSFour approaches: 1. CPAP 40 cm H2O 2. Peak pressure 40 cm H2O 3. PEEP 15 cm H2O for 300 sec 4. no intervention (controls) | Procedure or surgery | No recruitment, Recruitment 15x300, Recruitment 40x40, Recruitment PEAK40 |
Primary outcome
Respiratory support
Time frame: 24 hrs
The duration of the postoperative respiratory support
4 secondary outcomes
The incidence of postoperative atelectasis
Time frame: 24 hrs
Incidence of reintubation
Time frame: 24 Hrs
Oxygenation
Time frame: 12 hrs after extubation
Length of ICU and hospital stay
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Y. Kirov, MD, PhD study director
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar recruitment in people with Hypoxemia and Recruitment, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory support (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.