Evaluation of the i-gel supraglottic airway.

Evaluation of the i-gel supraglottic airway compared to a standard disposable laryngeal mask airway during Spontaneous and Continuous Positive Pressure Ventilation (CPPV) in patients receiving anesthesia for (non-thoracic, non-abdominal) elective surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25310

Enrollment

240

Registered

2007-10-28

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

1. i-gel

Interventions

Randomisation to i-gel or disposable laryngeal mask.

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA 1-2; 2. Adults (age 18 to 80 years); 3. Weight 40 – 100 kg; 4. Elective procedures; 5. Non-thoracic, non-abdominal surgery; 6. Non-pregnant; 7. Non-symptomatic of regurgitation.

Exclusion criteria

Exclusion criteria: 1. ASA 3 and above; 2. Below the age of 18 or above the age of 80; 3. Weight than 100kg; 4. Full stomach or symptomatic with regurgitation or retained gastric contents; 5. Thoracic or abdominal surgery; 6. Emergency surgery/anaesthetics; 7. Pregnancy; 8. Known difficult airway; 9. Expected difficult airway: Mallampati grade IV or mouth opening less than 2.5 cm; 10. Patients with head and neck cancer.

Design outcomes

Primary

Measure	Time frame
Comparing the incidence of postoperative sore throat after 1, 24 and 48 hours.	—

Secondary

Measure	Time frame
Comparing insertion and ventilation parameters, maximum seal power and fibre-optic evaluation of device position of the two supraglottic airway devices.	—

Contacts

Public ContactC. Keijzer

NKI, Plesmanlaan 121

c.keijzer@nki.nl+31 20-5129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)