search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Evaluation of the i-gel supraglottic airway.


- candidate number2840
- NTR NumberNTR1107
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2007
- Secondary IDsN07ISA  interne trial database
- Public TitleEvaluation of the i-gel supraglottic airway.
- Scientific TitleEvaluation 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.
- ACRONYMN/A
- hypothesisIn this study we will evaluate the use of the i-gel for airway management during induction and maintenance of anesthesia. The i-gel will be compared to the standard laryngeal mask (La premiere laryngeal mask, figure 2) now used in our institute. In a study from the manufacturer of the i-gel (not published) the incidence of sore throat in 442 i-gel insertions is 10.5%. In literature5 this incidence with laryngeal masks is 13% (5.8-34%). To demonstrate a significant difference in incidence of sore throat between the two groups, a power analysis calculated that 5400 patients should be included in this study (80% power, alpha 0.05). Because of the large range of incidence of sore throat with laryngeal masks (5.8 34%) we are expecting a higher incidence in this group then 13%. We therefore will start this study as a pilotstudy with the inclusion of 120 patients in both arms to obtain accurate incidence figures for sore throat with these specific airway devices.
- Healt Condition(s) or Problem(s) studiedAnesthesia, Sore throat
- Inclusion criteria1. 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 criteria1. ASA 3 and above;
2. Below the age of 18 or above the age of 80;
3. Weight < than 40 or > 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate1-dec-2007
- Target number of participants240
- InterventionsRandomisation to i-gel or disposable laryngeal mask.
- Primary outcomeComparing the incidence of postoperative sore throat after 1, 24 and 48 hours.
- Secondary outcomeComparing insertion and ventilation parameters, maximum seal power and fibre-optic evaluation of device position of the two supraglottic airway devices.
- TimepointsSore throat evaluation after 1, 24 and 48 hours.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES C. Keijzer
- CONTACT for SCIENTIFIC QUERIES C. Keijzer
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- PublicationsN/A
- Brief summaryIn this study we will evaluate the use of the i-gel for airway management during induction and maintenance of anesthesia. The i-gel will be compared to the standard laryngeal mask (La premiere laryngeal mask) now used in our institute. Primary objective: comparing the incidence of postoperative sore throat after 1, 24 and 48 hours.

Secondary objectives: comparing insertion and ventilation parameters, maximum seal power and fibre-optic evaluation of device position of the two supraglottic airway devices.
- Main changes (audit trail)
- RECORD28-okt-2007 - 13-jan-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl