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

• ClinicalTrials.gov Identifier: NCT03753022
• Recruitment Status: Unknown
• First Posted: November 26, 2018
• Last Update Posted: November 29, 2018
• Sponsor: Federal University of São Paulo
• Collaborator: Vanessa Marques Ferreira
• Information provided by (Responsible Party): Solange Guizilini, Federal University of São Paulo

Study Description

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Coronary Artery Bypass Grafting; Acute Lung Injury	Other: Group G5; Other: Group G10; Other: Group G15	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention 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 (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of PEEP on Parameters of Tissue Perfusion and Clinical Outcomes After Coronary Artery Bypass Graft Surgery - a Randomized Clinical Trial
• Actual Study Start Date: January 2012
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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]
3. 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

Secondary Outcome Measures :

1. 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
2. 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
3. Duration of mechanical ventilation [ Time Frame: Through study completion, an average of 24 hours after surgery ]
   Hours since surgery until extubation

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Solange Guizilini, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03753022
• Other Study ID Numbers: 89704818.6.0000.5505
• First Posted: November 26, 2018
• Last Update Posted: November 29, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Solange Guizilini, Federal University of São Paulo:

Acute Lung Injury; postoperative of cardiac surgery

Additional relevant MeSH terms:

Lung Injury; Acute Lung Injury; Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries