- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01917565
The Use of Airtraq Laryngoscope Versus Macintosh Laryngoscope and Fiberoptic Bronchoscope by Experienced Anesthesiologists
Studieoversigt
Status
Detaljeret beskrivelse
The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.
The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
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Istanbul, Kalkun, 34734
- Department of Anesthesiology, Marmara University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation
Exclusion Criteria:
- Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Airtraq laryngoscope group
The patients who will be intubated by using Airtraq laryngoscope
|
|
Macintosh laryngoscope group
The patients who will be intubated by using Macintosh laryngoscope
|
|
Fiberoptic bronchoscope group
The patients who will be intubated by using Fiberoptic bronchoscope
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The required time to successful tracheal intubation
Tidsramme: six months
|
The primary outcome variable is the required time to successful tracheal intubation
|
six months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The first-attempt success rate of tracheal intubation
Tidsramme: six months
|
The secondary outcome variable is the first-attempt success rate of tracheal intubation
|
six months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
the effects of the tracheal intubation on hemodynamic parameters
Tidsramme: six months
|
The other outcome variable is the effects of the tracheal intubation on hemodynamic parameters
|
six months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 09.2011.0127
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