Bariatric Surgery Candidate, Obesity
Conditions
Keywords
bariatric surgery, difficult airway, videolaringoscopy, intubation, airway managment, obesity and anesthesia, preoperative care
Brief summary
Background: Difficult airway in bariatric patients presents significant challenges during anesthesia, impacting patient safety and surgical outcomes. This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery. Materials and Methods: This prospective observational cohort study will be conducted in a single center. Patients over 18 years with a BMI ≥ 30 kg/m2 undergoing bariatric surgery and requiring intubation will be included. Data will be collected on patient demographics, clinical characteristics, and intubation outcomes. The primary outcome is the occurrence of difficult airway, defined by specific criteria including intubation difficulty and the need for alternative airway management techniques. Secondary outcomes include complications related to airway management and overall surgical outcomes. A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3%. Conclusions: Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors. The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions.
Interventions
PROCEDUREIntubation
Aiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx.
Sponsors
: Manuel Alberto Guerrero Gutierrez
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age * Patients of both genders * Patients diagnosed with BMI greater than or equal to 30 kg/m2 * Patients who will undergo bariatric surgery * Patients who require intubation for intraoperative ariway management
Exclusion criteria
* Patients who withdraw their consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of difficult airway | Day 1 | Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of difficult airway (anticipated or unanticipated difficulty or failure is experienced by a physician trained in anesthesia care, including but not limited to one or more of the following: facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation, or invasive airway). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe hypoxia | Day 1 | Cumulative incidence (expressed as percentage) of severe hypoxia, defined as a peripheral blood oxygen saturation (SpO2) lower than 80% during advanced airway management. |
| Incidence of cardiovascular collapse | Day 1 | Cumulative incidence (expressed as percentage) of cardiovascular collapse, defined as any of the following events within 30 minutes from induction to surgical incision: * Systolic blood pressure lower than 65 mmHg. * Dyastolic blood pressure ower than 90 mmHg for more than 15 minutes * Unplanned need for vasopressors or fluid loading greater than; 15 ml/kg to maintain target blood pressure. |
| Incidence of minor adverse events | Day 1 | Cumulative incidence (expressed as percentage) of minor adverse events, including: * Moderate hypoxia (SpO2 lower than 93%), * Airway injury, * Clinically relevant bleeding, * Oral aspiration of gastric contents, * Dental injury, * Lip injury. |
| Incidence of Difficult Facemask Ventilation | Day 1 | Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult Facemask Ventilation (It is not possible 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.). For operationalization, successful face mask ventilation with 2 hands will be consigned as the reference (No difficult face mask ventilation), whereas face mask ventilation attempts with 4 or 6 hands will be considered as the presence of difficult face mask ventilation. |
| Incidence of Difficult or Failed Tracheal Intubation | Day 1 | Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult or Failed Tracheal Intubation (Tracheal intubation requires multiple attempts or tracheal intubation fails after multiple attempts.). For operationalization, more than 1 attempt will be considered as Difficult or Failed Tracheal Intubation. |
Countries
Mexico
Outcome results
None listed