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

NCT05759299 | Recruiting

• 1 other identifier: STARGATE
• Study Type: observational
• Target: 10,500
• Locations: 5 countries
• Sites: 10

Brief Summary

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.

Conditions

Airway Complication of Anesthesia

Keywords

airway management; anesthesia

Outcome Measures

Primary Outcomes (1)

• Major peri-intubation adverse event

  Defined as at least one of the following events: * Cardiovascular collapse (at least one of the following): 1. Systolic arterial pressure \< 65 mmHg 2. Systolic arterial pressure \< 90 mmHg for \> 15 minutes 3. New 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 Outcomes (3)

• Minor peri-intubation adverse events

  30 minutes from induction

• Difficult facemask ventilation

  30 minutes from induction

• First pass success rate

  30 minutes from induction

Other Outcomes (4)

• Emergency front of neck access (eFONA)

  30 minutes from induction

• Cannot intubate cannot oxygenate (CICO)

  30 minutes from induction

• Unplanned need for ICU secondary to airway management complications

  24 hours from induction

Study Arms (1)

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)

Procedure: Advanced airway management

Interventions

Advanced airway management PROCEDURE

Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs

Patients undergoing anesthesia in operating room and outside operating room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (10)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Cochin University Hospital, Assistance Publique - Hôpitaux de Paris

Paris, France

RECRUITING

Tata Memorial Hospital

Mumbai, India

NOT YET RECRUITING

University Hospital of Galway

Galway, Ireland

NOT YET RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, TO, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza

Torino, TO, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

COMPLETED

Ospedale Santa Chiara, APSS Trento

Trento, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 18582931 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.

  PMID: 21447488 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.

  PMID: 29210033 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.

  PMID: 33755076 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.

  PMID: 35536310 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.

  PMID: 35917027 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.

  PMID: 26721639 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.

  PMID: 34762729 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.

  PMID: 23242753 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.

  PMID: 8665631 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.

  PMID: 28974066 BACKGROUND

Study Officials

• Vincenzo Russotto, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Francesca Collino, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Russotto, MD

CONTACT

+393297893044; vincenzo.russotto@unito.it

Francesca Collino, MD

CONTACT

+393334320985; francesca.collino@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 8, 2023
• Study Start: January 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

FR (1); US (2); IN (1); IE (1); IT (5)