- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00935636
An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.
The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235
- Chlidren's Medical Center Dallas
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation
- Patients age 0 - 2 years
- Weight up to 10 kg
- American Society of Anesthesiologists physical status I-III
Exclusion Criteria:
- Patients at risk of pulmonary aspiration,
- Increased intracranial pressure
- Those with congenital cardiac diseases or
- Those with hemodynamic instability
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to intubation
Tidsramme: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen
|
From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The time to laryngoscopic views, number of attempts, and the success rate
Tidsramme: from the time the device enters the mouth until the best view is acknowledged.
|
from the time the device enters the mouth until the best view is acknowledged.
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Peter Szmuk, MD, UT Southwestern
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 042009-046
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Intubation
-
Kaohsiung Medical University Chung-Ho Memorial...AfsluttetIntubation, Nasotracheal IntubationTaiwan
-
University Hospitals Coventry and Warwickshire...Oxford University Hospitals NHS TrustAfsluttetIntubation; Svært | Tracheal intubationDet Forenede Kongerige
-
Heinrich-Heine University, DuesseldorfAfsluttet
-
Spanish Network for Research in Infectious DiseasesAfsluttetIntubation | Intubationskomplikation | Intubation; Svært eller mislykketSpanien
-
Wake Forest University Health SciencesAfsluttetSvær intubation | Vågen endotracheal intubation | LuftvejsbedøvelseForenede Stater
-
Second Military Medical UniversityAfsluttetTransilluminations-guidet fiberoptisk intubation intubationKina
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)Ikke rekrutterer endnuEndotracheal intubation | Intubationskomplikation | Intubation; Svært eller mislykket
-
University Hospital, CaenAfsluttetLuftvejskomplikation af anæstesi | Intubation; Svært | Vågen intubationFrankrig
-
Catharina Ziekenhuis EindhovenAfsluttetAnæstesi Intubationskomplikation | Intubation; Svært | Mislykket eller vanskelig intubation | Mislykket eller vanskelig intubation, indledende mødeHolland
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RekrutteringIntubationskomplikation | Intubation; Svært | Mislykket eller vanskelig intubation, efterfølgerForenede Stater, Canada, Japan, Italien, New Zealand, Singapore, Australien, Østrig, Tyskland, Indien, Det Forenede Kongerige