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According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.
STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.
According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anesthesia in patients undergoing elective or emergency surgery and in the setting of non-operating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.
Study design: International, multicenter, prospective cohort study
Inclusion criteria: We will include all adult (≥ 18 years old) patients undergoing advanced airway management 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.
Primary outcome: At least one of the following major peri-intubation adverse events occurring within 30 minutes from induction or up to surgical incision: severe hypoxia, cardiovascular collapse, cardiac arrest.
Study duration: All centers will enroll all consecutive patients meeting study criteria up to 50 maximum patients for each center.
Collected data: We will collect the following information:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing anesthesia in operating room and outside operating room | Patients undergoing elective or emergency advanced airway management to receive general anesthesia for surgery in operating room or outside operating room (e.g. endoscopy and radiology unit, cardiology lab cath) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced airway management | Procedure | Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Major peri-intubation adverse event | Defined as at least one of the following events:
| 30 minutes from induction |
| Measure | Description | Time Frame |
|---|---|---|
| Minor peri-intubation adverse events | At least one of the following:
| 30 minutes from induction |
| Difficult facemask ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency front of neck access (eFONA) | Emergency need for invasive access to the patient's neck to provide adequate oxygenation (e.g. cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy). | 30 minutes from induction |
| Cannot intubate cannot oxygenate (CICO) |
Inclusion Criteria:
Exclusion Criteria:
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Adult, not critically ill patients, undergoing advanced airway management (i.e. tracheal intubation or supraglottic airways) to receive surgery or any kind of diagnostic or therapeutic procedure under general anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Russotto, MD | Contact | +393297893044 | vincenzo.russotto@unito.it | |
| Francesca Collino, MD | Contact | +393334320985 | francesca.collino@unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Russotto, MD | University of Turin, Italy | Principal Investigator |
| Francesca Collino, MD | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Not yet recruiting | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18582931 | Background | Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. | |
| 21447488 | Background | Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29. |
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Impossibility to provide adequate ventilation because of one or more of the following problems: inadequate mask seal, excessive gas leak, or excessive resistance to the ingress or egress of gas |
| 30 minutes from induction |
| First pass success rate | Incidence of successful intubation after a single attempt of laryngoscopy | 30 minutes from induction |
Impossibility to achieve a successful tracheal intubation and adequate patient's oxygenation |
| 30 minutes from induction |
| Unplanned need for ICU secondary to airway management complications | Unplanned admission to ICU after an airway-related complication or prolonged/difficult instrumentation | 24 hours from induction |
| In-hospital mortality | Death during the same hospital admission | 28 days from induction |
| MD Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| Cochin University Hospital, Assistance Publique - Hôpitaux de Paris | Recruiting | Paris | France |
|
| Tata Memorial Hospital | Not yet recruiting | Mumbai | India |
|
| University Hospital of Galway | Not yet recruiting | Galway | Ireland |
|
| Fondazione IRCCS San Gerardo dei Tintori | Not yet recruiting | Monza | Monza E Brianza | Italy |
|
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Not yet recruiting | Orbassano | TO | Italy |
|
| A.O.U. Città della Salute e della Scienza | Recruiting | Torino | TO | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Completed | Milan | Italy |
| Ospedale Santa Chiara, APSS Trento | Recruiting | Trento | Italy |
|
| 29210033 | Background | Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123. |
| 33755076 | Background | Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. |
| 35536310 | Background | Russotto V, Tassistro E, Myatra SN, Parotto M, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Pesenti A, Valsecchi MG, Fumagalli R, Foti G, Bellani G, Laffey JG. Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study. Am J Respir Crit Care Med. 2022 Aug 15;206(4):449-458. doi: 10.1164/rccm.202111-2575OC. |
| 35917027 | Background | Green RS, Erdogan M. Are outcomes worse in patients who develop post-intubation hypotension? CJEM. 2022 Aug;24(5):465-466. doi: 10.1007/s43678-022-00340-x. Epub 2022 Aug 2. No abstract available. |
| 26721639 | Background | Green RS, Butler MB. Postintubation Hypotension in General Anesthesia: A Retrospective Analysis. J Intensive Care Med. 2016 Dec;31(10):667-675. doi: 10.1177/0885066615597198. Epub 2016 Jul 7. |
| 34762729 | Background | Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002. |
| 23242753 | Background | Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393. |
| 8665631 | Background | Rose DK, Cohen MM. The incidence of airway problems depends on the definition used. Can J Anaesth. 1996 Jan;43(1):30-4. doi: 10.1007/BF03015954. |
| 28974066 | Background | Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127. |
| 41651535 | Derived | Russotto V, Sansovini C, Muraccini M, Collino F, Myatra SN, Higgs A, Brewster D, Curic Radivojevic R, Parotto M, Karamchandani K, Landoni G, Sorbello M, Monfroglio M, Rovescala G, Martinelli P, Tinelli O, Meessen J, Bellani G, Laffey JG, Langeron O, Caironi P. Multicentre international observational study on airway management for anaesthesia: the STARGATE study protocol. BMJ Open. 2026 Feb 6;16(2):e109038. doi: 10.1136/bmjopen-2025-109038. |