Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia
Conditions
Keywords
I-gel study, SGA study, Elderly patients
Brief summary
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and longer cuff tip for better sealing. The study aims to evaluate differences in sealing pressure and other performance metrics in this population, where anatomical changes may affect device efficacy.
Detailed description
Supraglottic airway devices (SGAs) are widely used as alternatives to endotracheal intubation in anesthesiology and emergency medicine. The I-gel® (Intersurgical Ltd., UK) features a non-inflatable cuff for ease of insertion and excellent sealing. The I-gel plus® improves on this with a larger gastric channel, better airway tube, and extended cuff tip to enhance sealing pressure. Prior studies compared I-gel® to other SGAs like ProSeal or Supreme, showing variable sealing pressures, but direct comparisons between I-gel® and I-gel plus®, especially in elderly patients, are lacking. Elderly patients may experience upper airway anatomical changes affecting SGA performance. Higher sealing pressure is crucial for surgeries with increased intra-abdominal pressure (e.g., laparoscopic or robotic surgery) and can reduce respiratory complications in patients with airway hypersensitivity. This prospective crossover study will quantitatively assess differences in sealing pressure, fixation stability, and other outcomes. Both devices are approved by the Korean MFDS and will be used within approved indications for academic evaluation of efficacy in elderly patients.
Interventions
DEVICEI-gel first
After general anesthesia, I-gel is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel plus is inserted, and the same procedure is repeated.
DEVICEI-gel plus first
After general anesthesia, I-gel plus is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel is inserted, and the same procedure is repeated.
BEHAVIORALcommon
Prior to general anesthesia, as a common baseline procedure for all study arms, the patient's Charlson Comorbidity Index and frailty score are assessed and recorded through patient evaluation (using the Clinical Frailty Scale for the frailty score). Immediately before induction of anesthesia, progressive pressures (100 g, 200 g, 300 g, 400 g, and 500 g) are applied to the patient's thyroid cartilage, and the degree of deviation is measured and documented.
Sponsors
Dongguk University International Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No blinding is implemented.
Intervention model description
Prospective crossover design where patients are randomized to receive either I-gel first followed by I-gel plus (Group I) or vice versa (Group P)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 65-85 years with ASA physical status I-III. * Scheduled for elective surgery under general anesthesia lasting less than 3 hours.
Exclusion criteria
* High risk of aspiration (history of gastrectomy, BMI \>35 kg/m², gastroesophageal reflux disease, hiatal hernia). * Poor dental status preventing I-gel fixation. * Cervical spine instability. * Anatomical abnormalities in mouth or larynx, or high risk of respiratory complications (asthma, COPD, recent pneumonia). * Pregnancy. * Other cases deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway Sealing Pressure | During surgery, immediately after each device insertion | Comparison of sealing pressure (cm H2O) between I-gel® and I-gel plus®, measured after insertion with fresh gas flow at 3 L/min and valve closed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fixation Stability | During surgery | Assessment of device position maintenance after insertion (device movement yes/no). |
| Time to Successful Insertion | During surgery | Time from start of insertion to complete EtCO2 curve appearance (twice). |
| Ease of Insertion | During surgery | Graded as 1 (success on first attempt, no resistance), 2 (success on first, with resistance), 3 (success after \>1 attempt). |
| Operator Complications | Post-surgery up to 24 hours | Incidence of sore throat, laryngospasm, voice hoarseness, dysphagia. |
Countries
South Korea
Outcome results
None listed