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- Essai clinique NCT02423317
Comparison of Miller's Blade and Airtraq Laryngoscope in Children
A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.
The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.
Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- American Society of Anesthesiologists physical status I-II,
- elective surgeries requiring tracheal intubation
Exclusion Criteria:
- patients with upper respiratory tract symptoms,
- those at risk of gastroesophageal regurgitation and
- those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Intubation with Miller's blade
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth.
After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Miller's blade.
|
Expérimental: Intubation with Airtraq laryngoscope
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth.
After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Airtraq.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Time to Intubation
Délai: 5 minutes
|
It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
|
5 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Intubation in First Attempts;
Délai: 5 minutes
|
A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.
|
5 minutes
|
Ease of Intubation.
Délai: 5 minutes
|
The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.
|
5 minutes
|
Percentage of Glottic Opening Scoring.
Délai: 5 minutes
|
The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch
|
5 minutes
|
Overall Intubation Success Rate.
Délai: 5 minutes
|
It is the number of participants who were successfully intubated after first, second or third attempts.
Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.
|
5 minutes
|
Number of Esophageal Intubation.
Délai: 5 minutes
|
Insertion of tracheal tube inside the esophagus
|
5 minutes
|
Number of Participants With Airway Trauma
Délai: 5 minutes
|
Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
|
5 minutes
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Shahin N Jamil, M.D., J.N.Medical College, Aligarh Muslim University
Publications et liens utiles
Publications générales
- Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
- Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
- White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AY, Medlock KE, Mason DG. A randomised, controlled trial comparing the Airtraq optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia. 2012 Mar;67(3):226-31. doi: 10.1111/j.1365-2044.2011.06978.x.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DN 182/FM
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