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Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia (Videoscopy)

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ClinicalTrials.gov Identifier: NCT03747250
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Brief Summary:
Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.

Condition or disease Intervention/treatment Phase
Tracheal Intubation Morbidity Device: Videolaryngoscopy Device: Direct laryngoscopy Not Applicable

Detailed Description:
Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Masking Description: The allocation to the group will be randomized in located in closed envelope, that will be opened in the operating theater before anesthesia induction
Primary Purpose: Treatment
Official Title: Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Arm Intervention/treatment
Experimental: Videolaryngoscopy
Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope
Device: Videolaryngoscopy
In experimental group (interventional group), patients will be intubated with the videolaryngoscope

Active Comparator: Direct laryngoscopy
Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy
Device: Direct laryngoscopy
In control group (active comparator group), patients will be intubated with the direct laryngoscope




Primary Outcome Measures :
  1. First intubation attempt success rate [ Time Frame: Intraoperatively ]
    Success rate of the first intubation attempt


Secondary Outcome Measures :
  1. Time for successful intubation [ Time Frame: Intraoperatively ]
    Time need for intubation from decision to intubate to first end-tidal CO2 wave

  2. Overall intubation success rate [ Time Frame: Intraoperatively ]
    Success rate fot intubation

  3. Laryngeal view [ Time Frame: Intraoperatively ]
    Laryngeal view scored by Cormack-Lehane grading system

  4. Complications [ Time Frame: Intraoperatively ]
    Incidence of associated complications during anesthesia induction - desaturation, bradycardia



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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients scheduled for elective surgery
  • Planned tracheal intubation for airway management during surgery
  • Signed informed consent

Exclusion Criteria:

  • Emergency surgery
  • Other airway management plan
  • age outside the predefined limits
  • Informed consent not signed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747250


Contacts
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Contact: Petr Štourač, assoc.Prof.MD.Ph.D 5 3223 4261 ext 00420 stourac.petr@fnbrno.cz
Contact: Jozef Klucka, MD 532234696 ext 00420 Klucka.jozef@fnbrno.cz

Locations
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Czechia
University Hospital Brno - FN Brno Recruiting
Brno, Czech Republic, Czechia, 62500
Contact: Petr Štourač, assoc.Prof.MD.Ph.D    532234691 ext 00420    stourac.petr@fnbrno.cz   
Contact: Jozef Klučka, MD    532234696 ext 00420    klucka.jozef@fnbrno.cz   
Sponsors and Collaborators
Brno University Hospital
Investigators
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Study Chair: Petr Štourač, assoc.Prof.MD.Ph.D KDAR FN Brno

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Responsible Party: Petr Štourač, MD, assoc.prof.MD,Ph.D, Brno University Hospital
ClinicalTrials.gov Identifier: NCT03747250     History of Changes
Other Study ID Numbers: KDAR FN Brno 2018/12
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Petr Štourač, MD, Brno University Hospital:
Videolaryngoscopy
Laryngoscopy
Tracheal intubation
Success rate
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs