Porovnání VIDIAC, PeDiAC a Škály obtížnosti intubace u dětských pacientů podstupujících videolaryngoskopickou intubaci (VIDIPEDIDS)
Prospektivní observační studie porovnávající VIDIAC, PeDiAC a stupnici obtížnosti intubace (IDS) u pediatrických pacientů ve věku 5–18 let podstupujících tracheální intubaci pomocí videolaryngoskopie
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Turkiye
-
Ankara, Turkiye, Turecko (Türkiye)
- Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children
Časové okno: Immediately after tracheal intubation
|
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
|
|
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
Časové okno: Immediately after tracheal intubation
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- VIDIPEDIIDS-25
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .