Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial

Brian O'Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor, Brian O'Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor

Abstract

Background: Patients undergoing cardiac surgery with cardiopulmonary bypass are at an increased risk of developing postoperative pulmonary complications, potentially leading to excess morbidity and mortality. It is likely that pulmonary ischemia-reperfusion (IR) injury during cardiopulmonary bypass is a major contributor to perioperative lung injury. Therefore, interventions that can minimize IR injury would be valuable in reducing the excess burden of this potentially preventable disease process. Volatile anesthetics including sevoflurane have been shown in both preclinical and human trials to effectively limit pulmonary inflammation in a number of settings including ischemia-reperfusion injury. However, this finding has not yet been demonstrated in the cardiac surgery population. The Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS) trial is a randomized controlled trial (RCT) investigating whether sevoflurane anesthetic maintenance can modulate pulmonary inflammation occurring during cardiac surgery with cardiopulmonary bypass and whether this potential effect can translate to a reduction in postoperative pulmonary complications.

Methods: APLICS is a prospective RCT of adult cardiac surgical patients. Participants will be randomized to receive intraoperative anesthetic maintenance with either sevoflurane or propofol. Patients in both groups will be ventilated according to protocols intended to minimize the influences of ventilator-induced lung injury and hyperoxia. Bronchoalveolar lavage (BAL) and blood sampling will take place after anesthetic induction and 2-4 h after pulmonary reperfusion. The primary outcome is a difference between groups in the degree of post-bypass lung inflammation, defined by BAL concentrations of TNFα. Secondary outcomes will include differences in additional relevant BAL and systemic inflammatory markers and the incidence of postoperative pulmonary complications.

Discussion: APLICS investigates whether anesthetic choice can influence lung inflammation and pulmonary outcomes following cardiac surgery with cardiopulmonary bypass. A positive result from this trial would add to the growing body of evidence describing the lung protective properties of the volatile anesthetics and potentially reduce unnecessary morbidity for cardiac surgery patients.

Trial registration: ClinicalTrials.gov, NCT02918877 . Registered on 29 September 2016.

Keywords: Cardiac surgery; Inflammatory lung injury; Postoperative pulmonary complications; TNFα; Volatile anesthetics.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
APLICS study schema. TIVA total intravenous anesthesia (propofol), IA inhaled anesthetic (sevoflurane), ICU intensive care unit
Fig. 2
Fig. 2
SPIRIT figure

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