International ObServational STudy On AiRway ManaGement In OperAting Room And Non-operaTing Room AnaEsthesia (STARGATE)

Overview

About this study

The purpose of this study is to assess the current incidence of major adverse events during advanced airway management in anaesthesia in patients undergoing elective or emergency surgery performed in the operating room (OR) and in the setting of nonoperating room anaesthesia (NORA). The secondary aim is to assess the current practice of airway management during anaesthesia worldwide.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • All adult (≥ 18 years old) patients undergoing intubation for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).

Exclusion Criteria:

  • Airway management during cardiopulmonary resuscitation.
  • Critically ill patients undergoing intubation due to their underlying clinical condition.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/3/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nathan Smischney, M.D., M.S.

Contact us for the latest status

Contact information:

Nathan Smischney

smischney.nathan@mayo.edu

More information

Publications

  • Cardiovascular instability/collapse is a common peri-intubation event in patients who are critically ill. To identify potentially modifiable variables associated with peri-intubation cardiovascular instability/collapse (i.e., systolic arterial pressure <65 mm Hg [once] or <90 mm Hg for >30 minutes; new/increased vasopressor requirement; fluid bolus >15 ml/kg, or cardiac arrest). INTUBE (International Observational Study to Understand the Impact and Best Practices of Airway Management In Critically Ill Patients) was a multicenter prospective cohort study of patients who were critically ill and undergoing tracheal intubation in a convenience sample of 197 sites from 29 countries across five continents from October 1, 2018, to July 31, 2019. A total of 2,760 patients were included in this analysis. Peri-intubation cardiovascular instability/collapse occurred in 1,199 out of 2,760 patients (43.4%). Variables associated with this event were older age (odds ratio [OR], 1.02; 95% confidence interval [CI], 1.02-1.03), higher heart rate (OR, 1.008; 95% CI, 1.004-1.012), lower systolic blood pressure (OR, 0.98; 95% CI, 0.98-0.99), lower oxygen saturation as measured by pulse oximetry/Fi before induction (OR, 0.998; 95% CI, 0.997-0.999), and the use of propofol as an induction agent (OR, 1.28; 95% CI, 1.05-1.57). Patients with peri-intubation cardiovascular instability/collapse were at a higher risk of ICU mortality with an adjusted OR of 2.47 (95% CI, 1.72-3.55),  < 0.001. The inverse probability of treatment weighting method identified the use of propofol as the only factor independently associated with cardiovascular instability/collapse (OR, 1.23; 95% CI, 1.02-1.49). When administered before induction, vasopressors (OR, 1.33; 95% CI, 0.84-2.11) or fluid boluses (OR, 1.17; 95% CI, 0.96-1.44) did not reduce the incidence of cardiovascular instability/collapse. Peri-intubation cardiovascular instability/collapse was associated with an increased risk of both ICU and 28-day mortality. The use of propofol for induction was identified as a modifiable intervention significantly associated with cardiovascular instability/collapse.Clinical trial registered with clinicaltrials.gov (NCT03616054). Read More on PubMed
  • The American Society of Anesthesiologists; All India Difficult Airway Association; European Airway Management Society; European Society of Anaesthesiology and Intensive Care; Italian Society of Anesthesiology, Analgesia, Resuscitation and Intensive Care; Learning, Teaching and Investigation Difficult Airway Group; Society for Airway Management; Society for Ambulatory Anesthesia; Society for Head and Neck Anesthesia; Society for Pediatric Anesthesia; Society of Critical Care Anesthesiologists; and the Trauma Anesthesiology Society present an updated report of the Practice Guidelines for Management of the Difficult Airway. Read More on PubMed
  • Tracheal intubation is one of the most commonly performed and high-risk interventions in critically ill patients. Limited information is available on adverse peri-intubation events. Read More on PubMed
  • Despite being infrequent, complications of airway management remain an important contributor to morbidity and mortality during anaesthesia and care of the critically ill. Developments in the last three decades have made anaesthesia safer, and this has been mirrored in the equipment and techniques available for airway management. Modern technology including novel oxygenation modalities, widespread availability of capnography, second-generation supraglottic airway devices and videolaryngoscopy provide the tools to make airway management safer still. However, technology will only take safety so far, and non-technical aspects of airway management are critically important for communication and decision making during airway crises, acknowledging a 'cannot intubate, cannot oxygenate' situation and transitioning to emergency front of neck airway. Randomised controlled trials provide little useful information about safety in this setting, and data from registries and databases are likely to be of more value. This narrative review focuses on recent evidence in this area. Read More on PubMed
  • We hypothesized that different phases of intraoperative hypotension should be differentiated because of different underlying causative mechanisms. We defined post-induction hypotension (PIH; i.e. arterial hypotension occurring during the first 20 min after anaesthesia induction) and early intraoperative hypotension (eIOH; i.e. arterial hypotension during the first 30 min of surgery). Read More on PubMed
  • Postintubation hypotension (PIH) is an adverse event associated with poor outcomes in emergency department endotracheal intubations. Study objective was to determine the incidence of PIH and its impact on outcomes following tracheal intubation in a general anesthesia population. Read More on PubMed
  • Airway management complications causing temporary patient harm are common, but serious injury is rare. Because most airways are easy, most complications occur in easy airways: these complications can and do lead to harm and death. Because these events are rare, most of our learning comes from large litigation and critical incident databases that help identify patterns and areas where care can be improved: but both have limitations. The recent 4th National Audit Project of the Royal College of Anaesthetists and Difficult Airway Society provides important detailed information and our best estimates of the incidence of major airway complications. A significant proportion of airway complications occur in Intensive Care Units and Emergency Departments, and these more frequently cause patient harm/death and are associated with suboptimal care. Hypoxia is the commonest cause of airway-related deaths. Obesity markedly increases risk of airway complications. Pulmonary aspiration remains the leading cause of airway-related anaesthetic deaths, most cases having identifiable risk factors. Unrecognized oesophageal intubation is not of only historical interest and is entirely avoidable. All airway management techniques fail and prediction scores are rather poor, so many failures are unanticipated. Avoidance of airway complications requires institutional and individual preparedness, careful assessment, good planning and judgement, good communication and teamwork, knowledge and use of a range of techniques and devices, and a willingness to stop performing techniques when they are failing. Analysis of major airway complications identifies areas where practice is suboptimal; research to improve understanding, prevention, and management of such complications remains an anaesthetic priority. Read More on PubMed
  • This project was devised to estimate the incidence of major complications of airway management during anaesthesia in the UK and to study these events. Read More on PubMed
  • Little is known about the amount and availability of surgical care globally. We estimated the number of major operations undertaken worldwide, described their distribution, and assessed the importance of surgical care in global public-health policy. Read More on PubMed
  • Definitions currently used to describe airway difficulties are confusing, inconsistent, and may be misleading. To understand the "extent of the problem" better using three different definitions we examined the corresponding rates of airway difficulty in 3,325 consecutive adult patients who had direct laryngoscopy with tracheal intubation following induction of general anaesthesia. Read More on PubMed
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CLS-20598527

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