The evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia

A prospective evaluation of the i-gel Plus supraglottic airway device in elective procedures

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86233693

Enrollment

2000

Registered

2019-12-16

Start date

2020-09-23

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Airway management in patients under general anaesthesia Surgery

Interventions

Intravenous induction with propofol, opioid (fentanyl, sufentanil). Muscle relaxant is not a part of the protocol. If given, for any reason, this must be reported to the CRF. Maintenance – air, oxygen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males or females 2. Age 18-89 years 3. American Society of Anesthesiologists classification (ASA) I-III status 4. Elective procedure without a need for muscle relaxation

Exclusion criteria

Exclusion criteria: 1. Age less than 18 or more than 89 years 2. American Society of Anesthesiologists classification (ASA) more than III status 3. Emergency surgery 4. Intra-abdominal operations, intrathoracic procedures 5. Increased risk for aspiration of gastric contents 6. BMI of more than 35 kg/m2 7. Unusual operating positioning – steep head down, prone, sitting 8. Incapacity to understand/sign informed consent (learning difficulties, language difficulties)

Design outcomes

Primary

Measure	Time frame
Success rate of device insertion (%), defined as the device providing effective oxygenation and ventilation without a significant leak. Timepoint: After device insertion, after induction to general anaesthesia.	—

Secondary

Measure	Time frame
1. Number of attempts (maximum three allowed). Timepoint: after induction to general anaesthesia 2. Oropharyngeal seal (leak) pressure (cmH20, maximum 40 cmH20). Timepoint: measured after insertion, at 30, 60 mins. 3. Insertion time (sec), measured from inserting the device between the teeth until connection to the anaesthetic machine. Timepoint: after induction to general anaesthesia. 4. Subjective assessment of insertion ease, measured using a 1-5 Likert scale. Timepoint: after insertion of the device. 5. Fiberoptic assessment of the device position, measured using a scale 1-4 (1- full view of the vocal cords, 2- partial view of the vocal cords only, 3- only epiglottis visible, 4- not even epiglottis visible). Timepoint: after device insertion. Note: this secondary outcome is eligible, it depends on the availability of flexible bronchoscope. 6. Insertion of the gastric tube measured using a 1-5 Likert scale. Timepoint: after insertion of the device. Note: this secondary outcome is eligible, it depends on clinical indication. 7. Perioperative complications – blood on the device, gastric contents inside the bowl, clinical signs of aspiration, laryngospasm, bronchospasm. Timepoint: at the end of the procedure, after the i-gel Plus removal. 8. Postoperative complications: 8.1. Sore throat (1-10 scale) 8.2. Pain on swallowing, swallowing difficulties (1-10 scale) 8.3. Hoarseness (1-10 scale) 8.4. Numb tongue, numbness inside the oral cavity (1-10 scale) 8.5. Cough 8.6. Neck pain (1-10 scale) 8.7. Jaw pain (1-10 scale) Timepoint: Measured by questionnaire at 1 and 24 hours post-procedure. Selected patients showing significant complaints at 24 hours will be contacted by telephone at 3 and 6 months after the procedure.	—

Measure

Time frame

1. Number of attempts (maximum three allowed). Timepoint: after induction to general anaesthesia 2. Oropharyngeal seal (leak) pressure (cmH20, maximum 40 cmH20). Timepoint: measured after insertion, at 30, 60 mins. 3. Insertion time (sec), measured from inserting the device between the teeth until connection to the anaesthetic machine. Timepoint: after induction to general anaesthesia. 4. Subjective assessment of insertion ease, measured using a 1-5 Likert scale. Timepoint: after insertion of the device. 5. Fiberoptic assessment of the device position, measured using a scale 1-4 (1- full view of the vocal cords, 2- partial view of the vocal cords only, 3- only epiglottis visible, 4- not even epiglottis visible). Timepoint: after device insertion. Note: this secondary outcome is eligible, it depends on the availability of flexible bronchoscope. 6. Insertion of the gastric tube measured using a 1-5 Likert scale. Timepoint: after insertion of the device. Note: this secondary outcome is eligible, it depends on clinical indication. 7. Perioperative complications – blood on the device, gastric contents inside the bowl, clinical signs of aspiration, laryngospasm, bronchospasm. Timepoint: at the end of the procedure, after the i-gel Plus removal. 8. Postoperative complications: 8.1. Sore throat (1-10 scale) 8.2. Pain on swallowing, swallowing difficulties (1-10 scale) 8.3. Hoarseness (1-10 scale) 8.4. Numb tongue, numbness inside the oral cavity (1-10 scale) 8.5. Cough 8.6. Neck pain (1-10 scale) 8.7. Jaw pain (1-10 scale) Timepoint: Measured by questionnaire at 1 and 24 hours post-procedure. Selected patients showing significant complaints at 24 hours will be contacted by telephone at 3 and 6 months after the procedure.

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Countries

Czech Republic, Northern Ireland, Poland, Spain, United Kingdom

Contacts

Public ContactJakub Werner

jakub.werner@vfn.cz+420 (0)224962243

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026