- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01003327
Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25
Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 During Elective Surgery
Studieoversikt
Detaljert beskrivelse
Inclusion criteria of this randomized cross-over study are: BMI > 25, elective surgery in supine position, age>18 years, ASA I-II; Exclusion criteria are: difficult airway, pregnancy, history of reflux or gastrointestinal disorders, abdominal or thoracic surgery; In this cross-over trial both airway devices are inserted in the same patient, the order of insertion is randomized. Patient receive monitoring with blood pressure, ECG and pulse oxymetry during operation. Anaesthesia is induced intravenously using fentanyl (0.001 mg/kg) and propofol (3-5 mg/kg). The I-gel laryngeal mask is inserted with a gastric tube. The classic laryngeal mask was cuffed after insertion with a cuff pressure of 60 cmH2O. The first device is removed 5 minutes after insertion and replaced by the second device. Ease of insertion is graded as very easy=1, easy=2, difficult=3 and very difficult=4. Leak pressure is measured by two tests: In the first test the spill valve is closed at a fresh gas flow of 6l/min and the minimum airway pressure at which gas leaked around the airway device is recorded by listening for an audible leak. In the second test leakage is measured during pressure controlled ventilation. Therefore we administer a fresh gas flow of 3l/min, FiO2 of 50%, inspiration to expiration ratio of 1:2 and a frequency of breathing of 12. Leakage can be measured by the respirator. We record inspiration pressure, mean pressure, plateau pressure, tidal volume and peep at which the first measurable leakage occurred.
For statistical analysis we will use t-tests with a power of 80% and a p < 0.05.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
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Vienna, Østerrike, 1090
- Medical university of vienna, General hospital of Vienna
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- BMI > 25, elective surgery in supine position,
- age > 18 years,
- ASA I-II;
Exclusion Criteria:
- difficult airway, pregnancy,
- history of reflux or gastrointestinal disorders,
- abdominal or thoracic surgery;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: I-gel inserted first
The I-gel airway is insewrted first, then the LMA-Unique
|
intubation with I-gel airway
|
|
Annen: LMA-Unique inserted first
LMA-Unique airway is inserted first, then the I-gel
|
LMA-Unique airway is inserted first, then the I-gel
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
leak pressure of the laryngeal masks
Tidsramme: directly after insertion of the laryngeal mask
|
directly after insertion of the laryngeal mask
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Insertion time and ease of insertion of the laryngeal mask
Tidsramme: during insertion of the laryngeal mask
|
during insertion of the laryngeal mask
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 354/2009
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