Clinical trial · Interventional
Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms
Ventilation Efficacy of I-gel® Size 3 and Size 4 Supraglottic Airway Devices in Anesthetized, Paralyzed Female Patients Weighing Between 50 and 60 Kilograms: a Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Masks | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| size 3 i-gel supraglottic airway device | Device | — | UNRESOLVED |
| size 4 i-gel supraglottic airway device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- size 3 i-gel®
- description
- size 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
- interventionNames
- Device: size 3 i-gel supraglottic airway device
- type
- EXPERIMENTAL
- label
- size 4 i-gel®
- description
- size 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
- interventionNames
- Device: size 4 i-gel supraglottic airway device
Primary outcomes (1)
- measure
- Compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 20 years old. * ASA physical status I and II. * Elective breast surgery. * Female with a body weight of 50 - 60 kilograms. Exclusion Criteria: * High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility) * Previous head \& neck surgery. * Previous head \& neck concurrent chemoradiotherapy (CCRT) * Reactive airway disease: chronic obstructive pulmonary disease (COPD), asthma, upper respiratory infection in recent two weeks * Exposure to tobacco * Pregnancy
References
Publications (0)
Data not yet available