- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07245511
VIDIAC:n, PeDiAC:n ja intubaatiovaikeusasteikon vertailu pediatrisissa potilaissa, joille suoritetaan videolaryngoskooppinen intubaatio (VIDIPEDIDS)
Prospektiivinen havainnointitutkimus, joka vertaa VIDIAC-, PeDiAC- ja intubaatiovaikeusasteikkoa (IDS) 5–18-vuotiailla lapsipotilailla, joille suoritetaan henkitorvansiirto videolaryngoskopialla
This prospective observational study aims to evaluate three scoring systems (VIDIAC (Video Laryngoscopic Intubation and Difficult Airway Classification), PeDiAC (Pediatric Difficult Airway Classification), and the Intubation Difficulty Scale (IDS)).
A total of 450 children undergoing general anesthesia with videolaryngoscopic intubation will be included in the study. Demographic data, intraoperative parameters, and glottic imaging, as well as detailed intubation-related variables such as total intubation time, number of attempts, complications, and subjective intubation ease scores will be recorded.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
This study is a prospective, observational, single-center study designed to compare three difficult intubation scales (VIDIAC [Video Laryngoscopic Intubation and Difficult Airway Classification], PeDiAC [Pediatric Difficult Airway Classification], and the Intubation Difficulty Scale [IDS]).
A total of 450 children undergoing elective or emergency surgery under general anesthesia at Ankara Bilkent City Hospital will be included in the study. All tracheal intubations will be performed using a C-MAC videolaryngoscope with an endotracheal tube appropriate for the child's age, weight, and surgical indication. No procedures beyond routine clinical practice will be performed, and informed consent will be obtained from parents or legal guardians prior to inclusion in the study.
Data collection will include demographic characteristics (age, gender, weight, height, ASA classification, comorbidities), intraoperative parameters (SpO₂, heart rate), and intubation-related variables: Glottic view graded using the modified Cormack-Lehane classification, time required for glottic visualization, total intubation time, number of attempts, use of adjuncts (stylet, bougie, alternative tubes), complications (desaturation, esophageal intubation, mucosal bleeding, tooth or lip trauma).
This study will evaluate difficult tracheal intubation in pediatric patients aged 5 to 18 years. Three difficult intubations The difficulty of intubation will be rated subjectively (0 = extremely easy, 10 = impossible) by the anesthesiologist performing the intubation and independently by an observer.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Turkiye
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Ankara, Turkiye, Turkki (Türkiye)
- Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
This study will include pediatric patients aged 5 to 18 years who are scheduled for elective or emergency surgery under general anesthesia at Ankara Bilkent City Hospital. All participants will require tracheal intubation performed with a C-MAC videolaryngoscope. Eligible patients will have an ASA physical status classification of I-IV. Written informed consent will be obtained from parents or legal guardians prior to enrollment. Patients undergoing awake fiberoptic intubation, those with a history of tracheal resection, or children younger than 5 years will be excluded.
Kuvaus
Eligible participants will be pediatric patients aged 5 to 18 years who are undergoing general anesthesia for any surgical procedure. All included patients must undergo tracheal intubation using a videolaryngoscope (C-MAC). Patients must have an ASA physical status classification of I to IV and written informed consent must be obtained from a parent or legal guardian prior to participation.
Inclusion Criteria:
- Pediatric patients between 5 and 18 years of age
- Undergoing general anesthesia for any type of surgical procedure
- ASA physical status classification I to IV
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Patients undergoing awake fiberoptic intubation
- History of tracheal resection or reconstruction surgery
- Refusal to participate or absence of informed consent
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
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Pediatric Patients Undergoing Videolaryngoscopic Intubation
This cohort will include pediatric patients aged 5 to 18 years undergoing elective or emergency surgery under general anesthesia who require tracheal intubation. All patients will be intubated using a C-MAC videolaryngoscope. Each intubation will be evaluated using the VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scoring systems. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children
Aikaikkuna: Immediately after tracheal intubation
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For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children. |
Immediately after tracheal intubation
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A Prospective Observational Study Comparing VIDIAC, PeDiAC, and the Intubation Difficulty Scale (IDS) in Assessing Difficult Intubation in Pediatric Patients Aged 5-18 Years Undergoing Tracheal Intubation with Videolaryngoscopy
Aikaikkuna: Immediately after tracheal intubation
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For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children. |
Immediately after tracheal intubation
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- VIDIPEDIIDS-25
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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