International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE)

Rationale

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 prospective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as periintubation 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 increases 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 in anaesthesia in patients undergoing elective or emergency surgery performed in the operating room (OR) and in the setting of nonoperating room anaesthesia (NORA). The secondary aim is to assess the current practice of airway management during anaesthesia worldwide.

Study design

International, multicentre, prospective cohort study

Data collection

We will collect the following information:

1. Informed consent and admission data

2. Demographic and clinical characteristics

3. Type of procedure (time, setting, type of surgery, elective or emergency

4.  Airway evaluation (anticipated difficult airway management)

5. Monitoring applied during the procedure

6. Patient’s parameters

7. Preoxygenation method and use of apnoeic oxygenation (position during preoxygenation, rapid sequence induction applied)

8. Drugs used for induction (specific drug and doses)

9. Elective method of airway management

10. Operator’s characteristics

11. Method used for the second (and following) attempts

12. Method used for adequate tube placement confirmation

13. Duration of the procedure

14. Outcome of endotracheal intubation (total number of attempts, laryngoscopy view, minimum SpO2 during laryngoscopy, need for SGA)

15. Advanced airway management-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 (eFONA), cannot intubate cannot oxygenate scenario (CICO), unplanned need for ICU secondary to airway management complications)

16. Extubation procedure.

17. In-hospital mortality.

Statistical analysis

We will report mean and standard deviation of normally distributed variables and we will compare them using the student T-test. We will report non-normally distributed variables as median and interquartile range, comparing them using the Mann-Whitney U test. Categorical variables will be expressed as proportion and compared using the Chi-square or Fisher exact test as appropriate. We will perform a bivariate analysis to identify variables associated with the composite outcome of major peri-intubation adverse events and significant variables will be then used to construct a multivariate logistic model in order to identify independent variables. The following planned secondary analyses will be performed:

1. Place of advanced airway management: OR vs NORA

2. Type of surgery: cardiac vs non-cardiac surgery

3. Urgency of the procedure: planned advanced airway management vs unplanned advanced airway management

4. Type of hypnotic drug used: propofol vs different drug

5. Airway management procedure: difficult airway management vs not difficult

6. Patient’s condition: a. ASA 1-2 vs ASA 3-4; b. BMI<30 vs BMI>30;

A two-sided p-value < 0.05 will be considered statistically significant. Statistical analysis will be performed by IBM SPSS Statistics for Macintosh, Version 28.0. Armonk, NY: IBM Corp.

PUBLICATION AND AUTHORSHIP POLICY

The main results of STARGATE study will be published in a peer–reviewed international medical journal. Authorship policy will follow the International Committee of Medical Journal Editors (ICMJE) recommendations. Authorship will be considered based on contributions to recruitment of patients, data acquisition and cleaning, analysis and interpretation of the data, manuscript writing, submission of national/local grants AND final approval of the version to be published AND agreement to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Members of the Steering Committee will be part of the Writing Committee and listed as Authors. National Coordinators and particularly committed investigators fulfilling the previously exposed criteria will be part of the Writing Committee. Each centre will designate local coordinators who will provide scientific and structural leadership in their centres. They will ensure that all local necessary ethical and regulatory approvals are obtained before the start of patient inclusion. Local coordinators will guarantee the integrity of data collection and ensure timely completion of CRFs. Local coordinators will be listed as study collaborators in proportion to the number of recruited patients in each center.