- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03920748
Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants
Evaluation of the Relationship Between Airway Measurements With Ultrasonography and Laryngoscopic View in Newborn and Infants
Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.
Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.
Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.
The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.
Statistical analysis:
Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p <0.05 are considered as statistically significant.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ankara, Tacchino, 06110
- Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Newborn and infant age group
- Undergoing elective surgery requiring intubation under general anesthesia
Exclusion Criteria:
- History of congenital maxillofacial defect,
- History of upper airway pathology (tumor, cleft palate-lips, etc.)
- History of head and neck trauma (fracture, swelling, scar )
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Difficult laryngoscopy (Group D)
Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification.
According to this classification, patients are divided into two groups, patients with grade 3-4 are classified as difficult laryngoscopy ( Group D).
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According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D
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Easy laryngoscopy (Group E)
Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification.
According to this classification, patients are divided into two groups, patients with grade 1-2 are classified as easy laryngoscopy ( Group E).
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According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Thyromental distance (TMD)
Lasso di tempo: 1 hour
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The thyromental distance, unit of measure cm, is detected using a US linear probe with the transducer placed in the transverse plane.
Thyromental distance is measured in cm as straight line from thyroid notch to lower border of mentum with head extended in all patients.
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1 hour
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Other airway measurements
Lasso di tempo: 1 hour
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The other primary objective of this study is to identify if any preanesthetic airway assessment maneuvers (such as mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements) would be associated with difficult laryngoscopy in newborn and infants.
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1 hour
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Demographic data
Lasso di tempo: 1 hour
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The secondary objective of this study is to identify if factors such as age, sex, bady mass index (BMI) and physical status grade would be associated with grade III and IV laryngoscope views in newborn and infants.
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1 hour
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Feyza Sever, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2018105
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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