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Method Article
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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 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, randomized controlled trial of adult cardiac surgical patients. Subjects 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 between two to four hours after pulmonary reperfusion. The primary outcome is a difference between groups in the degree of post-bypass lung inflammation, defined by BAL concentrations of TNFa. 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 identifier NCT02918877, registered on September 29, 2016.
Keywords
Inflammatory lung injury, volatile anesthetics, cardiac surgery, postoperative pulmonary complications, TNFa
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 06 May, 2019
Review #1 received
Received 09 Apr, 2019
Reviewer #1 agreed
On 04 Apr, 2019
Reviewers invited
Invitations sent on 03 Apr, 2019
Submission checks complete
On 28 Mar, 2019
Editor assigned
On 28 Mar, 2019
Version 2
Posted 17 Jan, 2019
No comments provided
Editorial decision: Minor revision
On 08 Mar, 2019
Review #1 received
Received 28 Feb, 2019
Review #2 received
Received 27 Feb, 2019
Reviewer #2 agreed
On 26 Feb, 2019
Reviewer #1 agreed
On 21 Feb, 2019
Reviewers invited
Invitations sent on 22 Jan, 2019
Editor assigned
On 14 Jan, 2019
No comments provided
Editorial decision: Revise
On 02 Jan, 2019
Review #2 received
Received 22 Dec, 2018
Review #1 received
Received 12 Dec, 2018
Reviewer #2 agreed
On 02 Dec, 2018
Reviewer #1 agreed
On 27 Nov, 2018
Reviewers invited
Invitations sent on 26 Nov, 2018
Editor assigned
On 15 Nov, 2018
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Method Article
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 06 May, 2019
Review #1 received
Received 09 Apr, 2019
Reviewer #1 agreed
On 04 Apr, 2019
Reviewers invited
Invitations sent on 03 Apr, 2019
Submission checks complete
On 28 Mar, 2019
Editor assigned
On 28 Mar, 2019
Version 2
Posted 17 Jan, 2019
No comments provided
Editorial decision: Minor revision
On 08 Mar, 2019
Review #1 received
Received 28 Feb, 2019
Review #2 received
Received 27 Feb, 2019
Reviewer #2 agreed
On 26 Feb, 2019
Reviewer #1 agreed
On 21 Feb, 2019
Reviewers invited
Invitations sent on 22 Jan, 2019
Editor assigned
On 14 Jan, 2019
No comments provided
Editorial decision: Revise
On 02 Jan, 2019
Review #2 received
Received 22 Dec, 2018
Review #1 received
Received 12 Dec, 2018
Reviewer #2 agreed
On 02 Dec, 2018
Reviewer #1 agreed
On 27 Nov, 2018
Reviewers invited
Invitations sent on 26 Nov, 2018
Editor assigned
On 15 Nov, 2018
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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 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, randomized controlled trial of adult cardiac surgical patients. Subjects 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 between two to four hours after pulmonary reperfusion. The primary outcome is a difference between groups in the degree of post-bypass lung inflammation, defined by BAL concentrations of TNFa. 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 identifier NCT02918877, registered on September 29, 2016.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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