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

Airway Complication of Anesthesia Clinical Trial

— STARGATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759299
• Other study ID #: STARGATE
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Turin, Italy
• Contact: Vincenzo Russotto, MD
• Phone: +393297893044
• Email: vincenzo.russotto[@]unito.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Procedure:
• Tracheal intubation
Advanced airway management with tracheal intubation performed after induction with hypnotic and/or opioid drugs and laryngoscopy

Locations

Country	Name	City	State
France	Cochin University Hospital, Assistance Publique - Hôpitaux de Paris	Paris
India	Tata Memorial Hospital	Mumbai
Ireland	University Hospital of Galway	Galway
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milan
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Monza E Brianza
Italy	Azienda Ospedaliera Universitaria San Luigi Gonzaga	Orbassano	TO
Italy	A.O.U. Città della Salute e della Scienza	Torino	TO
Italy	Ospedale Santa Chiara, APSS Trento	Trento
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Countries where clinical trial is conducted

United States,  France,  India,  Ireland,  Italy, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Cannot intubate cannot oxygenate (CICO)	Impossibility to achieve a successful tracheal intubation and adequate patient's oxygenation	30 minutes from induction
Other	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
Other	In-hospital mortality	Death during the same hospital admission	28 days from induction
Primary	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 mmHg; Systolic arterial pressure < 90 mmHg for > 15 minutes; 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	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
Secondary	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
Secondary	First pass success rate	Incidence of successful intubation after a single attempt of laryngoscopy	30 minutes from induction