Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery

November 27, 2018 updated by: Solange Guizilini, Federal University of São Paulo

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective and isolated CABG, ejection fraction greater than 40%

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SHAM_COMPARATOR: Group G5
Patients submitted to CABG and peep 5
Other: Group G5
Submitted to peep 5
EXPERIMENTAL: Group G10
Patients submitted to CABG and peep 10
Other: Group G10
Submitted to peep 10
EXPERIMENTAL: Group G15
Patients submitted to CABG and peep 15
Other: Group G15
Submitted to peep 15

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 24 hours after surgery
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]
Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
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
Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 ]
Days since surgery until ICU discharge
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 ]
Days since surgery until Hospital discharge
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
Hours since surgery until extubation
Through study completion, an average of 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanessa Marques Ferreira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 89704818.6.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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