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A prospective randomised comparison of I-gel and LMA-unique Supraglottic Airway Devices for use during Clinical Anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39871601
Enrollment
300
Registered
2007-09-28
Start date
2006-05-18
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Surgery: Anaesthesia Surgery

Interventions

1. Selection of research participants 2. Explanation of research proposal and procedure, including provision of written information sheet and sufficient time for questions 3. Written consent 4. Rand

Sponsors

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ASA I or II patients (fit and healthy or with minor well-controlled chronic disease) 2. Age 16-70 years 3. Weight 30-120 kg 4. Not pregnant 5. Booked for elective surgery of duration <2 hours 6. Fasted 7. Normal airway assessment 8. Consenting

Exclusion criteria

Exclusion criteria: 1. Age 80, or weight 120kg 2. Pregnancy 3. Emergency surgery 4. Surgery > 2 hours duration 5. Patient not fit (ASA >=III) 6. Patient not starved 7. History of symptomatic reflux disease 8. History of difficult airway mgmt during previous anaesthesia 9. Anticipated difficult airway 10. Previous radiotherapy to head/neck 11. Heavy smokers >20 cigarettes/d 12. Non-consenting

Design outcomes

Primary

MeasureTime frame
Clinically successful placement of the device, ie 'successful insertion' and 'adequate leak pressure'.

Secondary

MeasureTime frame
Incidence of complications and post-operative presence of any subjective difficulty or pain with speaking, swallowing, jaw or neck movement, or any alteration to hearing or tongue sensation.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026