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Comparison of Miller's Blade and Airtraq Laryngoscope in Children

11. februar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 10 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / 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.
Enhed: Intubation with Miller's blade
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
Eksperimentel: 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.
Enhed: Intubation with Airtraq
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Intubation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Intubation in First Attempts;
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 5 minutes
Insertion of tracheal tube inside the esophagus
5 minutes
Number of Participants With Airway Trauma
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Government Medical College, Haldwani

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2013

Primær færdiggørelse (Faktiske)

1. maj 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

29. marts 2015

Først indsendt, der opfyldte QC-kriterier

21. april 2015

Først opslået (Skøn)

22. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DN 182/FM

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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