Airway Complication of AnesthesiaSTARGATENCT05759299
International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
An observational study of Airway Complication of Anesthesia, run by University of Turin, Italy at 10 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Advanced airway management
- Type of treatment
- Surgery or procedure
- How many people
- 10,500 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 15 Jan 2024to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).
Who cannot join
- Airway management during cardiopulmonary resuscitation.
- Critically ill patients undergoing intubation due to their underlying clinical condition
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
Italy5 sites, 4 recruiting
- Completed
ASST Grande Ospedale Metropolitano Niguarda
Milan
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza
Emanuele Rezoagli
- Not yet recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, TO
Vincenzo Russotto, 3297893044, vinrussotto@gmail.com
- Recruiting
A.O.U. Città della Salute e della Scienza
Torino, TO
Francesca Collino
- Recruiting
Ospedale Santa Chiara, APSS Trento
Trento
Giacomo Bellani
Silvia De Rosa
United States2 sites, 2 recruiting
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Kunal Karamchandani
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Juan Cata, JCata@mdanderson.org
France1 site, 1 recruiting
- Recruiting
Cochin University Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Olivier Langeron
India1 site, 1 recruiting
- Not yet recruiting
Tata Memorial Hospital
Mumbai
Sheila Myatra
Ireland1 site, 1 recruiting
- Not yet recruiting
University Hospital of Galway
Galway
John G Laffey
About this study
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.
Read the 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 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:
- 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.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Advanced airway management
- Keywords
- airway management, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced airway managementProcedure or surgery
Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Advanced airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 30 minutes from induction
Secondary outcomes (3)
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
Measured: 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
Measured: 30 minutes from induction
First pass success rate
Incidence of successful intubation after a single attempt of laryngoscopy
Measured: 30 minutes from induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Jan 2024
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Russotto, MD, Principal investigator, University of Turin, ItalyFrancesca Collino, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759299
- Sponsor's protocol ID
- STARGATE
- Acronym
- STARGATE
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18582931Cook 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.
PubMed 21447488Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.
PubMed 29210033Russotto 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.
PubMed 33755076Russotto 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.
PubMed 35536310Green 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.
PubMed 35917027Green 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.
PubMed 26721639Apfelbaum 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.
PubMed 34762729Cook 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.
PubMed 23242753Rose 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.
PubMed 8665631Sudfeld 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.
PubMed 28974066Russotto 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.
PubMed 41651535
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
- ClinicalTrials.gov ID
- NCT05759299
- Acronym / sponsor ID
- STARGATE / STARGATE
- Conditions
- Airway Complication of Anesthesia
- Keywords
- airway management, anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,500 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing anesthesia in operating room and outside operating room | – | Procedure: Advanced airway managementPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).
Key exclusion criteria (2 listed)
- Airway management during cardiopulmonary resuscitation.
- Critically ill patients undergoing intubation due to their underlying clinical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced airway managementAdvanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs | Procedure or surgery | Patients undergoing anesthesia in operating room and outside operating room |
Primary outcome
Major peri-intubation adverse event
Time frame: 30 minutes from induction
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%)
3 secondary outcomes
Minor peri-intubation adverse events
Time frame: 30 minutes from induction
Difficult facemask ventilation
Time frame: 30 minutes from induction
First pass success rate
Time frame: 30 minutes from induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 18582931Weiser 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.
- Background: PubMed 21447488Cook 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.
- Background: PubMed 29210033Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.
- Background: PubMed 33755076Russotto 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.
- Background: PubMed 35536310Russotto 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.
- Background: PubMed 35917027Green 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.
- Background: PubMed 26721639Green 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.
- Background: PubMed 34762729Apfelbaum 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.
- Background: PubMed 23242753Cook 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.
- Background: PubMed 8665631Rose 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.
- Background: PubMed 28974066Sudfeld 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.
- Derived from this study: PubMed 41651535Russotto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Russotto, MD principal investigator
University of Turin, Italy
Francesca Collino, MD principal investigator
University of Turin, Italy
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia, run by University of Turin, Italy at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, United States, France, India, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Russotto, MD (+393297893044, vincenzo.russotto@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major peri-intubation adverse event (time frame: 30 minutes from induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759299, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.