Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04108130
Status:
RECRUITING
Last Update Posted:
2023-02-03
First Post:
2019-09-26
Brief Title:
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications The PRIME-AIR Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications The PRIME-AIR Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME-AIR
Brief Summary:
Postoperative pulmonary complications PPCs are a major cause of morbidity and mortality in surgical patients National estimates suggest 1062000 PPCs per year with 46200 deaths and 48 million additional days of hospitalization The objective of the study is to develop and implement perioperative strategies to eliminate PPCs in abdominal surgery the field with the largest absolute number of PPCs We will conduct a randomized controlled pragmatic trial in 750 studied participants The effectiveness of an individualized perioperative anesthesia-centered bundle will be compared to the usual anesthetic care in patients receiving open abdominal surgery At the end of this project the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity The research will be conducted across 14 US academic centers and will be funded by the National Institute of Health
Detailed Description:
Postoperative pulmonary complications PPCs are a major cause of morbidity and mortality in surgical patients National estimates suggest 1062000 PPCs per year with 46200 deaths and 48 million additional days of hospitalization Abdominal surgery is the field with the largest absolute number of PPCs The long-term goal is to develop and implement perioperative strategies to eliminate PPCs Whereas PPCs are as significant and lethal as cardiac complications research in the field has received much less attention and strategies to minimize PPCs are regrettably limited Recently the investigators and others have suggested a crucial role of anesthesia related interventions such as ventilatory strategies and administration and reversal of neuromuscular blocking agents in reducing PPCs These findings are consistent with the beneficial effects of lung protective ventilation during the adult respiratory distress syndrome ARDS While surgical patients differ substantially from ARDS patients as most have no or limited lung injury at the start of surgery intraoperative anesthetic and abdominal surgery interventions result in lung derecruitment and predispose to or produce direct and indirect potentially multiple-hit lung injury Thus effective anesthetic strategies aiming at early lung protection in this group of patients are greatly needed Indeed the current lack of evidence results in wide and unexplained variability in anesthetic practices creating a major public health issue as some practices within usual care appear to be suboptimal and even potentially injurious The investigators hypothesize that an anesthesia-centered bundle based on recent findings and focused on perioperative lung protection will minimize multiple and synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction and result in decreased incidence and severity of PPCs Founded on strong preliminary data we will leverage a network of US academic centers to study this hypothesis in two aims Aim 1 To compare the number and severity of PPCs in participants receiving an individualized perioperative anesthesia-centered bundle to those in participants receiving usual anesthetic care during open abdominal surgery For this the investigators propose to conduct a prospective multicenter randomized controlled pragmatic trial with a blinded assessor in a total of 750 studied participants The bundle will consist of optimal mechanical ventilation comprising individualized positive end-expiratory pressure to maximize respiratory system compliance and minimize driving pressures individualized use of neuromuscular blocking agents and their reversal and postoperative lung expansion and early mobilization Aim 2 To assess the effect of the proposed bundle on plasma levels of lung injury biomarkers The investigators theorize that our intervention will minimize overinflation and atelectasis reducing plasma levels of biomarkers of lung inflammatory epithelial and endothelial injury Such mechanistic insights will facilitate bundle dissemination and support adoption as it has for lung protective ventilation for ARDS At the end of this project the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL140177 | OTHER | MGH | None |