Comparison of Miller's Blade and Airtraq Laryngoscope in Children
11 februari 2016 bijgewerkt door: Bikramjit Das, Government Medical College, Haldwani
A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
The Airtraq optical laryngoscope has recently been available in pediatric sizes.
The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients.
This prospective, randomized study was conducted in a tertiary care teaching hospital.
Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope.
The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score.
We also measured hemodynamic changes and airway trauma.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
2 jaar tot 10 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to Intubation
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Intubation in First Attempts;
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 5 minutes
|
Insertion of tracheal tube inside the esophagus
|
5 minutes
|
|
Number of Participants With Airway Trauma
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Shahin N Jamil, M.D., J.N.Medical College, Aligarh Muslim University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2013
Primaire voltooiing (Werkelijk)
1 mei 2014
Studie voltooiing (Werkelijk)
1 mei 2014
Studieregistratiedata
Eerst ingediend
29 maart 2015
Eerst ingediend dat voldeed aan de QC-criteria
21 april 2015
Eerst geplaatst (Schatting)
22 april 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
9 maart 2016
Laatste update ingediend die voldeed aan QC-criteria
11 februari 2016
Laatst geverifieerd
1 februari 2016
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- DN 182/FM
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