Coronary Artery DiseaseNCT03753022
Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery
A study testing Group G5, Group G10 and Group G15 in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Federal University of São Paulo.
Trial summary
Pulmonary dysfunction is a condition inherent in cardiac surgery because of various interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and establishment of internal thoracic artery dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Acute Lung Injury
- What is being tested?
- Group G5, Group G10 and Group G15
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2019
- 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
- elective and isolated CABG, ejection fraction greater than 40%
Who cannot join
- patients with a diagnosis of pulmonary disease, emergency surgery and mechanical ventilation prior to surgery.
- Postoperative patients who had radiological abnormalities suggestive of pneumothorax, atrial or ventricular arrhythmias, electrical ischemic changes on ECG, pulse pressure variation of more than 13, hemodynamic instability characterized by mean arterial pressure less than 60 mmHg, nor epinephrine greater than 0.5 mcg/Kg/ min and the presence of increased bleeding through the drains (greater than 2 ml \ kg \ h) the protocol was discontinued and the patient excluded from the study.
About this study
Official title: Effects of PEEP on Parameters of Tissue Perfusion and Clinical Outcomes After Coronary Artery Bypass Graft Surgery - a Randomized Clinical Trial
Pulmonary dysfunction is a condition inherent in cardiac surgery because of various interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and establishment of internal thoracic artery dissection.
In situations when there is a deterioration in oxygenation, increased positive pressure on the airways end pressure (PEEP) can be used as therapeutic mode by reversing severe hypoxemia resulting pulmonary shunt. But the use of PEEP has been associated to reduced cardiac output, due mainly to decrease systemic venous return consequent to increased intrathoracic pressure, and thus might reduce tissue oxygenation. Moreover, the increased transpulmonary gradient may also impair right ventricular ejection exacerbating the hemodynamic consequences in some patients, which in clinical practice this diagnosis may be difficult to perform.
Read more
In hypovolemic patients or those with cardiac changes may become even more pronounced, resulting in accentuation of low flow and systemic hypotension entailing changes in markers of tissue perfusion commonly measured by venous saturation central difference venoarterial carbon dioxide and lactate. The hypothesis of the investigators is that PEEP of 10 cmH2O and 15 cmH2O can be applied to reverse lung damage in patients in the immediate postoperative myocardial revascularization without repercussion tissue importantly in markers of tissue perfusion.
The objective is to evaluate the effects of different optimization levels of PEEP on gas exchange and influences the tissue perfusion after coronary artery bypass graft surgery.
Read the detailed description
This is a prospective, randomized study and will be performed on patients who accept coronary artery bypass grafting with cardiopulmonary bypass, the conscious openness to participate in the study. Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and cardiopulmonary bypass (CPB) time (min), cross clamp time (min), duration of operation, postoperative extubation period, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cmH2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)]. At each time of protocol (0, 1 and 2) will be collected: arterial blood gas measurements (partial pressure of arterial oxygen [PaO2] and partial pressure of carbon dioxide ([PaCO2]), the ratio between the partial oxygen pressure, inspired oxygen fraction (PaO2/FiO2) and pH. Also, will be performed parameters of tissue perfusion: central venous oxygen saturation ([SVO2]), arterial blood lactate, venoarterial CO2 difference ([Dif VA CO2]) and vital signs. In all other respects, treatment will follow the standard of care.
- Being tested
- Group G5, Group G10, Group G15
- Keywords
- Acute Lung Injury, postoperative of cardiac surgery
- Medical subject headings
- Coronary Artery Disease, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group G5Other
Submitted to peep 5
Group G10Other
Submitted to peep 10
Group G15Other
Submitted to peep 15
| Study group | Role | What they receive |
|---|---|---|
| Group G5 | Sham comparator | Patients submitted to CABG and peep 5 Receives: Other: Group G5 |
| Group G10 | Experimental | Patients submitted to CABG and peep 10 Receives: Other: Group G10 |
| Group G15 | Experimental | Patients submitted to CABG and peep 15 Receives: Other: Group G15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary events
Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis
Measured: Through study completion, an average of 24 hours after surgery
Arterial oxygenation
arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]
Measured: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
Tissue oxygenation
(central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference
Measured: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
Secondary outcomes (3)
Length of intensive care unit (ICU) stay
Days since surgery until ICU discharge
Measured: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]
Length of Hospital Stay
Days since surgery until Hospital discharge
Measured: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]
Duration of mechanical ventilation
Hours since surgery until extubation
Measured: Through study completion, an average of 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startJan 2012
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Sequential
- Model description
- The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 \[after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cm H2O (time 2)\]. Group G15 \[after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)\].
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Vanessa Marques Ferreira
- Responsible party
- Principal investigator, Solange Guizilini, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753022
- Sponsor's protocol ID
- 89704818.6.0000.5505
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PEEP on Parameters of Tissue Perfusion and Clinical Outcomes After Coronary Artery Bypass Graft Surgery - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03753022
- Acronym / sponsor ID
- 89704818.6.0000.5505
- Keywords
- Acute Lung Injury, postoperative of cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Vanessa Marques Ferreira
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Nov 2018 (actual)
- 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.
Pulmonary dysfunction is a condition inherent in cardiac surgery because of various interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and establishment of internal thoracic artery dissection.
In situations when there is a deterioration in oxygenation, increased positive pressure on the airways end pressure (PEEP) can be used as therapeutic mode by reversing severe hypoxemia resulting pulmonary shunt. But the use of PEEP has been associated to reduced cardiac output, due mainly to decrease systemic venous return consequent to increased intrathoracic pressure, and thus might reduce tissue oxygenation. Moreover, the increased transpulmonary gradient may also impair right ventricular ejection exacerbating the hemodynamic consequences in some patients, which in clinical practice this diagnosis may be difficult to perform.
In hypovolemic patients or those with cardiac changes may become even more pronounced, resulting in accentuation of low flow and systemic hypotension entailing changes in markers of tissue perfusion commonly measured by venous saturation central difference venoarterial carbon dioxide and lactate. The hypothesis of the investigators is that PEEP of 10 cmH2O and 15 cmH2O can be applied to reverse lung damage in patients in the immediate postoperative myocardial revascularization without repercussion tissue importantly in markers of tissue perfusion.
The objective is to evaluate the effects of different optimization levels of PEEP on gas exchange and influences the tissue perfusion after coronary artery bypass graft surgery.
Detailed description
This is a prospective, randomized study and will be performed on patients who accept coronary artery bypass grafting with cardiopulmonary bypass, the conscious openness to participate in the study. Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and cardiopulmonary bypass (CPB) time (min), cross clamp time (min), duration of operation, postoperative extubation period, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cmH2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)]. At each time of protocol (0, 1 and 2) will be collected: arterial blood gas measurements (partial pressure of arterial oxygen [PaO2] and partial pressure of carbon dioxide ([PaCO2]), the ratio between the partial oxygen pressure, inspired oxygen fraction (PaO2/FiO2) and pH. Also, will be performed parameters of tissue perfusion: central venous oxygen saturation ([SVO2]), arterial blood lactate, venoarterial CO2 difference ([Dif VA CO2]) and vital signs. In all other respects, treatment will follow the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cm H2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)].
| Arm | Type | Receives |
|---|---|---|
| Group G5 | Sham comparator | Other: Group G5Patients submitted to CABG and peep 5 |
| Group G10 | Experimental | Other: Group G10Patients submitted to CABG and peep 10 |
| Group G15 | Experimental | Other: Group G15Patients submitted to CABG and peep 15 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective and isolated CABG, ejection fraction greater than 40%
Key exclusion criteria (2 listed)
- patients with a diagnosis of pulmonary disease, emergency surgery and mechanical ventilation prior to surgery.
- Postoperative patients who had radiological abnormalities suggestive of pneumothorax, atrial or ventricular arrhythmias, electrical ischemic changes on ECG, pulse pressure variation of more than 13, hemodynamic instability characterized by mean arterial pressure less than 60 mmHg, nor epinephrine greater than 0.5 mcg/Kg/ min and the presence of increased bleeding through the drains (greater than 2 ml \ kg \ h) the protocol was discontinued and the patient excluded from the study.
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 |
|---|---|---|
| Group G5Submitted to peep 5 | Other | Group G5 |
| Group G10Submitted to peep 10 | Other | Group G10 |
| Group G15Submitted to peep 15 | Other | Group G15 |
Primary outcome
Pulmonary events
Time frame: Through study completion, an average of 24 hours after surgery
Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis
Arterial oxygenation
Time frame: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]
Tissue oxygenation
Time frame: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
(central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference
3 secondary outcomes
Length of intensive care unit (ICU) stay
Time frame: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]
Length of Hospital Stay
Time frame: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]
Duration of mechanical ventilation
Time frame: Through study completion, an average of 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group G5, Group G10 and Group G15 in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Federal University of São Paulo.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pulmonary events (time frame: Through study completion, an average of 24 hours after surgery). The study lists 3 primary outcomes in all. 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 29 Nov 2018.