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

Not Applicable

• Conditions: Airway management in patients under general anaesthesia; Surgery

• Registration Number: ISRCTN86233693
• Lead Sponsor: Vseobecna fakultni nemocnice (General University Hospital)

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34930740/ (added 22/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Last Update Posted: 13 March 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2000

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.