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

NCT03753022 | Unknown

• 1 other identifier: 89704818.6.0000.5505
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting; Acute Lung Injury

Keywords

Acute Lung Injury; postoperative of cardiac surgery

Outcome Measures

Primary Outcomes (3)

• 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

  Through study completion, an average of 24 hours after surgery

• Arterial oxygenation

  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

  (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 Outcomes (3)

• Length of intensive care unit (ICU) stay

  From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]

• Length of Hospital Stay

  From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]

• Duration of mechanical ventilation

  Through study completion, an average of 24 hours after surgery

Study Arms (3)

Group G5

SHAM COMPARATOR

Patients submitted to CABG and peep 5

Other: Group G5

Group G10

EXPERIMENTAL

Patients submitted to CABG and peep 10

Other: Group G10

Group G15

EXPERIMENTAL

Patients submitted to CABG and peep 15

Other: Group G15

Interventions

Group G5 OTHER

Submitted to peep 5

Group G5

Group G10 OTHER

Submitted to peep 10

Group G10

Group G15 OTHER

Submitted to peep 15

Group G15

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Vanessa Marques Ferreira: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Acute Lung Injury

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 \[after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)\].

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: January 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 29, 2018

Record last verified: 2018-11