Clinical Trials Logo

Clinical Trial Summary

Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 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.


Clinical Trial Description

Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 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 Design


Related Conditions & MeSH terms

  • Postoperative Pulmonary Complications

NCT number NCT04108130
Study type Interventional
Source Columbia University
Contact Marcos F Vidal Melo, MD
Phone 212 342 4799
Email mv2869@cumc.columbia.edu
Status Recruiting
Phase N/A
Start date January 27, 2020
Completion date July 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06021249 - Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients N/A
Not yet recruiting NCT06023017 - The Effect of Preoperative Prone Position Training on PPCs in Patients Undergoing Laparoscopic Sleeve Gastrectomy N/A
Active, not recruiting NCT06304779 - The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Not yet recruiting NCT05519657 - Incidence and Risk Factors of PPCs in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery
Recruiting NCT06150079 - Individualized PEEP Titration on Postoperative Pulmonary Complications N/A
Completed NCT04605250 - Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period N/A
Not yet recruiting NCT02732574 - Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery N/A
Not yet recruiting NCT05830474 - Effect of Continuous Intra-airway Monitoring Under Visible Double-lumen Bronchial Catheter on Postoperative Complications of Lung Surgery N/A
Completed NCT05401253 - The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery
Not yet recruiting NCT06304493 - REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU) N/A
Completed NCT02918877 - Anesthetics to Prevent Lung Injury in Cardiac Surgery Phase 1/Phase 2
Not yet recruiting NCT06396767 - Diaphragmatic Inspiratory Amplitude as a Prognosticator for Postoperative Pulmonary Complications After Cardiac Surgery
Recruiting NCT04408495 - Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients N/A
Recruiting NCT05515809 - Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery Phase 3
Recruiting NCT05922449 - Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery N/A
Not yet recruiting NCT05671926 - Different Algorithm Models to Predict Postoperative Pneumonia in Elderly Patients
Not yet recruiting NCT05671939 - Different Algorithm Models to Predict Postoperative Pulmonary Complications in Elderly Patients
Not yet recruiting NCT05701449 - Prevention and Treatment of Perioperative Lung Injury in Elderly Patients
Not yet recruiting NCT05671952 - Multi-center Study on Reducing Postoperative Pulmonary Complications in Elderly Patients N/A