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An observational study of i-gel Plus

i-gel Plus for non-elderly and elderly patients: a prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1042230158
Enrollment
64
Registered
2024-02-27
Start date
2024-02-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cardiac and non-obstetric diseases for which supraglottic airway is indicated supraglottic airway device, airway management, general anesthesia

Interventions

None listed

Sponsors

Nakanishi Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Men and women between the ages of 18 and 70 or over the age of 70. (2) Patients scheduled for non-cardiac or non-obstetric surgery (excluding thoracic surgery such as lung and mediastinal surgery, supine surgery such as spine, head and neck surgery, and major surgery with a scheduled operating time of 4 hours or more) for which supraglottic instruments are applicable, under general anesthesia. (3) Patients whose written consent has been obtained.

Exclusion criteria

Exclusion criteria: (1) Patients who are pregnant or who may become pregnant. (2) Patients whose intent cannot be confirmed (3) Patients who are not fasting or suspected of not fasting (4) Patients at high risk for regurgitation or aspiration of gastric contents, such as those with gastroesophageal reflux disease, bowel obstruction, hiatal hernia, post-esophageal surgery, post-total gastrectomy, or severe obesity. (5) Patients with anatomical abnormalities, obstructive lesions, abscesses, or trauma to the respiratory tract (oral cavity, pharynx, larynx, trachea, or bronchi), or a history of treatment such as surgery or radiation. (6) Patients intubated prior to surgery (7) Patients expected to have difficulty securing the airway (opening less than 2.5 cm, limited neck range of motion, history of difficult intubation) (8) Patients with obvious hoarseness or sore throat prior to surgery. (9) Patients who are expected to have difficulty communicating postoperatively due to dementia, sequelae of cerebrovascular disease, etc. (10) Other patients deemed inappropriate by the research group.

Design outcomes

Primary

MeasureTime frame
Seal pressure

Secondary

MeasureTime frame
Success rate of i-gel Plus placement, number of attempts until successful placement, and time taken for successful placement Presence or absence of lip, tongue, oral, pharyngeal, or dental injury or bleeding Presence or absence of bubble test, Success rate of gastric tube insertion, number of attempts to insert a gastric tube, and time taken to successful insertion of a gastric tube, Fiber score, seal pressure, presence of blood on the i-gel Plus during its removal Hoarseness and sore throat in the PACU and the day after surgery Length of postoperative hospital stay

Contacts

Public ContactToshiyuki Nakanishi

Nagoya City University Hospital

nakanishi.anest@gmail.com+81-52-853-8281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026