International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia (STARGATE)

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 peri-intubation adverse events during 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Procedure: Tracheal intubation

Detailed Description

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 peri-intubation adverse events during 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 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.

Primary outcome: At least one of the following major peri-intubation adverse events occurring within 30 minutes from intubation 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:

• Informed consent and admission data
• Demographic and clinical characteristics
• Type of procedure (time, setting, type of surgery, elective or emergency
• Airway evaluation (anticipated difficult airway management)
• Monitoring applied during the procedure
• Patient's parameters
• Preoxygenation method and use of apnoeic oxygenation (position during preoxygenation, rapid sequence induction applied)
• Drugs used for induction (molecules and doses)
• Elective method for laryngoscopy
• Operator's characteristics
• Method used for the second (and following) attempt
• Method used for adequate tube placement confirmation
• Duration of laryngoscopy
• Outcome of endotracheal intubation (total number of attempts, laryngoscopy view, minimum SpO2 during laryngoscopy, need for LMA)
• Intubation-related complications (severe cardiovascular collapse, severe and mild hypoxemia, cardiac arrest, airway injury or any bleeding, aspiration of gastric contents, dental injury, emergency front of neck airway (FONA), cannot intubate cannot oxygenate scenario (CICO), unplanned need for ICU secondary to airway management complications)
• Extubation procedure.

• Study Type: Observational
• Enrollment (Estimated): 10500

Contacts and Locations

• Study Contact: Name: Vincenzo Russotto, MD; Phone Number: +393297893044; Email: vincenzo.russotto@unito.it
• Study Contact Backup: Name: Francesca Collino, MD; Phone Number: +393334320985; Email: francesca.collino@unito.it

Study Locations

• France
  • Paris, France
    • Cochin University Hospital, Assistance Publique - Hôpitaux de Paris
• India
  • Mumbai, India
    • Tata Memorial Hospital
    • Contact: Sheila Myatra
• Ireland
  • Galway, Ireland
    • University Hospital of Galway
    • Contact: John G Laffey
• Italy
  • Milan, Italy
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: Vito Torrano
  • Trento, Italy
    • Ospedale Santa Chiara, APSS Trento
    • Contact: Giacomo Bellani
    • Contact: Silvia De Rosa
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy
      • Fondazione IRCCS San Gerardo dei Tintori
      • Contact: Emanuele Rezoagli
  • TO
    • Orbassano, TO, Italy
      • Azienda Ospedaliera Universitaria San Luigi Gonzaga
      • Contact: Vincenzo Russotto; Phone Number: 3297893044; Email: vinrussotto@gmail.com
    • Torino, TO, Italy
      • A.O.U. Città della Salute e della Scienza
      • Contact: Francesca Collino
• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Contact: Kunal Karamchandani
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
      • Contact: Juan Cata; Email: JCata@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult, not critically ill patients, undergoing intubation to receive surgery or any kind of diagnostic or therapeutic procedure under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing anesthesia in operating room and outside operating room; Patients undergoing elective or emergency tracheal intubation to receive general anesthesia for surgery in operating room or outside operating room (e.g. endoscopy and radiology unit, cardiology lab cath)	Procedure: Tracheal intubation; Advanced airway management with tracheal intubation performed after induction with hypnotic and/or opioid drugs and laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major peri-intubation adverse event	Defined as at least one of the following events: Cardiovascular collapse (at least one of the following):Systolic arterial pressure < 65 mmHgSystolic arterial pressure < 90 mmHg for > 15 minutesNew need of vasopressors and/or fluid load > 15 ml/kg to maintain the target blood pressure; Cardiac arrest; Severe hypoxemia (SpO2 < 80%)	30 minutes from induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor peri-intubation adverse events	At least one of the following: Moderate hypoxia (SpO2 < 93%); Airway injury; Clinically relevant bleeding; Oral aspiration of gastric contents; Dental injury	30 minutes from induction
Difficult facemask ventilation	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Vincenzo Russotto, MD, University of Turin, Italy; Principal Investigator: Francesca Collino, MD, University of Turin, Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.
• 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. Erratum In: JAMA. 2021 May 24;:null.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: anesthesia; airway management
• Other Study ID Numbers: STARGATE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No