SQUEEZE Study : A prospective multi-centre international observational study of postoperative vasopressor use

SQUEEZE Study: Investigating Post-Operative Vasopressor Usage and Patient Outcomes in Non-Cardiac SurgeryThe SQUEEZE study investigates and enhance post-surgery outcomes through nvestigating the influence of vasopressor use in over 25,000 patients worldwide.Postoperative complications after major noncardiac surgery contribute significantly to early mortality. In particular, if "death within 30 days after surgery" was classified as a disease, it would rank as the third leading cause of death worldwide. Among these complications, vasoplegia is prevalent; however, there is a gap in understanding how to mitigate poor postoperative outcomes and premature death. This gap requires research focused on improving postoperative care, especially considering the low rates of intraoperative mortality in recent decades. The SQUEEZE study aims to address this knowledge gap by exploring the impact of postoperative use of vasopressors on patient outcomes. This study is a prospective, international, multicentre observational cohort study. The three-year data collection phase is complete, and the team is currently engaged in data cleansing and quality control, expecting to retain data from more than 25,000 patients from over 250 hospitals worldwide. The team anticipates an extensive data analysis phase through 2024, culminating in the submission of the primary article. The SQUEEZe study is expected to have a substantial impact on patients undergoing surgery. With the high volume of surgeries performed globally, even a minor reduction in morbidity and mortality can significantly improve patient outcomes and quality of healthcare. Additionally, the results will strengthen the position of participating health research institutions and healthcare authorities in perioperative research. This study provides crucial insights into the management of postoperative hypotension, a common issue with potentially severe outcomes. Currently, there is considerable anecdotal evidence of varied management practices in regions. The findings of the SQUEEZE study could lead to more standardised and effective approaches to the treatment of postoperative vasoplegia, thereby improving global patient safety and quality of treatment during the perioperative period. The SQUEEZE study is supported by the European Society of Anesthesiology and is endorsed by the European Society of Intensive Care.

SQUEEZE Study : A prospective multi-centre international observational study of postoperative vasopressor useDeath "within 30 days after surgery” is currently the third leading cause of death worldwide. Vasoplegia and hypotention after surgery is also common and associated with post-operative complications. The SQUEEZE study investigates the incidence and association of post-operative vasopressor usage and postoperative complications.Overall, the SQUEEZE study is delayed due to the COVID-19 pandemic for a minimum of two years. We now plan the end of data collection for the third quartile of 2023. Since 2022, the study has been accepted as a UK research portfolio study through a seperate study approval for the UK. This approval means we got access to the NHS research infrastructure to advertise and run the study in the UK. We now expect a significant number of hospitals to contribute from the UK. Currently, 45 hospitals finalized data collection, and 296 hospitals from 51 countries are recruiting or entering data into the electronic database. On the 31st of December 2022, there were 22.198 patients enrolled on the database. Quality control and data validation happen continuingly. We closed recruiting more hospitals, and the steering committee is now focusing on motivating active centres to continue recruiting and transferring data. A substatial amount of work is going into data cleaning, communication with participating hospitals and preparing primary data analysis that will happen during autumn 2023. The statistical analysis plan for SQUEEZE and the study protocol is currently under peer review for publication in "Perioperative Medicine Journal". The designated study website (www.squeezestudy.com) is regularly updated, and all relevant study documents are available there. Consent- and information sheets are translated into 33 languages, which are also available on the website. The SQUEEZE study is endorsed by 20 different national anesthesiology societies as well as from the American Society of Anaesthesiology and the European Society of Intensive Care Medicine.

SQUEEZE study: A prospective mulit-centre international observational study of postoperative vasopressor useDeath "within 30 days after surgery” is currently the third leading cause of death worldwide. Vasoplegia and hypotention after surgery is also common and associated with post-operative complications. The SQUEEZE study investigates the incidence and association of post-operative vasopressor usage and postoperative complications.Recently we got study approval for the UK. The study was accepted as a research portfolio study, meaning that we got access to the NHS research infrastructure to advertise and run the study in the UK. We now expect a significant numbers of hospitals contributing from there. Overall, the SQUEEZE study is expected to be delayed due to the COVID-19 pandemic for minimum two years. End of data collection is now anticipated for the second quartile 2023. Currently 42 hospitals finalized data collection and 209 are currently recruiting or entering data info the electronic database. Over 15.000 patients are as today enrolled into the database. Quality control and data validation happens on a continuing basis. The study is still accepting more participating hospitals and the steering committee is actively recruiting centers. The statistical analysis plan for SQUEEZE is finalized and send for publication together with the study protocol to a peer reviewed journal for publication. The designated study website (www.squeezestudy.com) is regularly updated, all relevant study documents are available there. Consent- and information sheets have been translated into 26 languages, all these are also available on the website. The SQUEEZE study is endorsed by 20 different national anesthesiology societies as well as from the American Society of Anaesthesiology and the European Society of Intensive Care Medicine. Although the study is running well globally, we run into unexpected difficulties when applying for the study in Norway. Especially communication with the data privacy ombudsman (PVO = personvernombud) raised concerns: The GDPR is interpreted very strict by the PVO. Although the GDPR states that the regulation should not restrict health research, the PVO does apply the same rules for commercial interest onto non-commercial research. This is difficult to understand. The PVOs in the different hospitals also interpret the regulations different. This makes multi-center research nearly impossible in Norway: A approved project in one health region can be rejected in another. We do not understand why data privacy cannot have a national approval as there are in ethics. The strict interpretation of the regulation of data transfer in other EU countries is difficult to understand. Especially when de-identified data is stored on a research platform within the EU that follows the same GDPR rules. The PVO shall, as an advisor, guide researchers and help them understand the regulations. In practice, they are a major hindrance and constantly place new demands on researchers. How to solve these requirements is up to the researcher himself to find out. The sum of this led to a massive amount of application work and regulatory problems for the Norwegian part of the study and nearly caused the Norwegian part to drop out. We had to use a completely disproportionate amount of time that caused a one-year delay of the study start in Norway. This is a real hindrance to scientific work and cannot be in line with either the intention of the GDPR or the privacy ombudsman's intended role. One very promising PhD student resigned from the project as a direct consequence of the application process.

SQUEEZE study: A prospective mulit-centre international observational study of postoperative vasopressor useDeath "within 30 days after surgery” is currently the third leading cause of death worldwide. Vasoplegia and hypotention after surgery is also common and associated with post-operative complications. The SQUEEZE study investigates the incidence and association of post-operative vasopressor usage and postoperative complications.Currently are globally 500 hospitals participating in SQUEEZE. Every country has its designated national coordinator. Each hospital has a principal investigator and a team of collaborators that help collecting data. The anticipated sample size is 52.000 patients. Each center collects data of all patients undergoing non-cardiac surgery during the index week (Cohort A) followed by collecting consecutive patients that receive postoperative vasopressors (Cohort B) until the goal of 30 patients per center is reached or until one year has passed. The SQUEEZE data will be the largest prospectively collected dataset of serious postoperative complications and would have sufficient generalizability on the practice of postoperative care on an international basis. The SQUEEZE study received a grant by the European Society of Anaesthesiology and Intensive Care and get significant administrative support from its research department. The electronic case report form was finalized January 2020, data collection planned to start in March 2020. Due to the global COVID-19 pandemic, many participating hospitals cancelled elective surgery in March to prepare for an anticipated influx of patient with respiratory problem. Data collection was therefore not possible for the majority of countries. This continued to be a problem for many hospitals throughout the year. Start of data collection had to be postponed to latest March 2021. We expect that some countries that currently are heavily affected by a surge of COVID-19 patients have to further postpone data collection (UK, USA, Netherlands, Germany and others). However, some countries that were not heavily affected managed to collect data for Cohort A. Overall, the SQUEEZE study is expected to be delayed due to the COVID-19 pandemic for minimum a year. End of data collection is now anticipated for March 2022 and closing of the database for autumn 2022. Currently there are 8000 patients entered into the electronic database. Quality control and data validation happens on a continuing basis. The study is still accepting more participating hospitals and the steering committee is actively recruiting centers. The statistical analysis plan for SQUEEZE is currently finalized and will be send for publication together with the study protocol to a peer reviewed journal for publication before data analysis. The designated study website (www.squeezestudy.com) is regularly updated, all relevant study documents are available there. Consent- and information sheets have been translated into 26 languages, all these are also available on the website. The SQUEEZE study is now endorsed by 20 different national anesthesiology societies as well as from the American Society of Anaesthesiology and the European Society of Intensive Care Medicine.