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Laryngoscopy for Neonatal and Infant aIrway Management (Optimise-Trial) (Optimise)

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ClinicalTrials.gov Identifier: NCT04295902
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
University of Bern
Gaslini Children's Hospital
Children's Hospital of Philadelphia
Montreal Children's Hospital of the MUHC
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The objective of this study is to compare tracheal intubation first attempt success rate with the C-MAC indirect videolaryngoscope (Karl Storz, Germany) using a Miller-Blade nr 0 or nr 1 compared to a standard direct laryngoscope with standard blades Miller nr 0 and Miller nr 1 with oxygen supplementation either in the operating room or intensive care to demonstrate that with oxygen supplementation the difference in the first-attempt success rate in favor of VL is negligible

Condition or disease Intervention/treatment Phase
Airway Management Device: C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1. Device: Direct laryngoscope with blades Miller nr 0 and Miller nr 1. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Laryngoscopy for Neonatal and Infant aIrway Management wIth Supplemental oxygEn (OPTIMISE): a Multi-center Prospective Randomized Controlled Trial
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: VL-group
Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Germany) with blades Miller nr 0 and Miller nr 1.
Device: C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1.
Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Tuttlingen, Germany) with blades Miller nr 0 and Miller nr 1.
Other Name: C-Mac Videolaryngoscope

Active Comparator: DL-group
Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1
Device: Direct laryngoscope with blades Miller nr 0 and Miller nr 1.
Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1
Other Name: Standard direct laryngoscope




Primary Outcome Measures :
  1. Tracheal intubation first attempt success rate [ Time Frame: 15 minutes ]
    Primary outcome is tracheal intubation first attempt success rate with the C-MAC indirect videolaryngoscope (Karl Storz, Germany) using a Miller-Blade nr 0 or nr 1 compared to a standard direct laryngoscope with standard blades Miller nr 0 and Miller nr 1.


Secondary Outcome Measures :
  1. Occurrence and duration of moderate and severe desaturation [ Time Frame: 15 minutes ]
    Occurrence and duration of moderate and severe desaturation (SpO2 < 90% and SpO2 < 80%), with or without bradycardia, during intubation

  2. Overall number of attempts [ Time Frame: 15 minutes ]
    Overall number of intubation's attempts

  3. Time required for intubation [ Time Frame: 5 minutes ]
    Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography),

  4. First EtCO2 after successful intubation [ Time Frame: 10 minutes ]
    First EtCO2 after successful intubation

  5. Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy [ Time Frame: 5 minutes ]
    Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy

  6. Use of additional devices [ Time Frame: 10 minutes ]
    The need for additional devices used at any step of intubation, the need to switch from one technique to another

  7. Respiratory complications [ Time Frame: 24 hours ]
    Respiratory complications or complications of airway management within the first 24 hours such airway injury, mechanical resuscitation, bleeding, aspiration of gastric contents, post extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients requiring tracheal intubation for elective, semi-elective or urgent surgical and non-surgical indications either in the pediatric operating room, the pediatric or neonatal intensive care unit
  • Children aged up to 52 weeks (corrected gestational age), with legal guardians providing written informed consent before the intervention

Exclusion Criteria:

  • Prediction of difficult intubation upon physical examination or previous history of difficult intubation, mandating a technique different than direct laryngoscopy to secure the airway
  • congenital heart disease mandating FiO2 < 1.0
  • cardiopulmonary collapse requiring advanced life support
  • intubation for emergency surgical and non-surgical indications

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): NCT04295902


Contacts
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Contact: Thomas Riva, MD +41316321709 thomasriva@me.com
Contact: Robert Greif, MD +41316322111 robert.greif@insel.ch

Locations
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Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Thomas Riva, MD    +41326321709    thomas.riva@insel.ch   
Principal Investigator: John Fiadjoe, MD         
Principal Investigator: Nicola Disma, MD         
Principal Investigator: Alexandra Petre, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Gaslini Children's Hospital
Children's Hospital of Philadelphia
Montreal Children's Hospital of the MUHC
Investigators
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Study Chair: Thomas Riva, MD University of Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04295902    
Other Study ID Numbers: 2019-02454
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pyrithione zinc
Keratolytic Agents
Dermatologic Agents