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Comparison of Miller's Blade and Airtraq Laryngoscope in Children

11 februari 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 10 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status I-II,
  2. elective surgeries requiring tracheal intubation

Exclusion Criteria:

  1. patients with upper respiratory tract symptoms,
  2. those at risk of gastroesophageal regurgitation and
  3. those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhet: Intubation with Miller's blade
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
Experimentell: 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.
Enhet: Intubation with Airtraq
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Intubation
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Intubation in First Attempts;
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 5 minutes
Insertion of tracheal tube inside the esophagus
5 minutes
Number of Participants With Airway Trauma
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Government Medical College, Haldwani

Utredare

  • Studierektor: Shahin N Jamil, M.D., J.N.Medical College, Aligarh Muslim University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2013

Primärt slutförande (Faktisk)

1 maj 2014

Avslutad studie (Faktisk)

1 maj 2014

Studieregistreringsdatum

Först inskickad

29 mars 2015

Först inskickad som uppfyllde QC-kriterierna

21 april 2015

Första postat (Uppskatta)

22 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 mars 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 februari 2016

Senast verifierad

1 februari 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • DN 182/FM

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