An observational study of i-gel Plus

JRCT ID: jRCT1042230158

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-cardiac and non-obstetric diseases for which supraglottic airway is indicated
• Date of first enrollment: 27/02/2024
• Target sample size: 64
• Study type: Observational

Outcome(s)

• Primary Outcome: Seal pressure

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nakanishi Toshiyuki