NCT04295902

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

March 2, 2020

Last Update Submit

March 8, 2023

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

  • Tracheal intubation first attempt success rate

    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.

    15 minutes

Secondary Outcomes (7)

  • Occurrence and duration of moderate and severe desaturation

    15 minutes

  • Overall number of attempts

    15 minutes

  • Time required for intubation

    5 minutes

  • First EtCO2 after successful intubation

    10 minutes

  • Percentage of Glottic Opening (POGO) score at any attempt of laryngoscopy

    5 minutes

  • +2 more secondary outcomes

Study Arms (2)

VL-group

EXPERIMENTAL

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.

DL-group

ACTIVE COMPARATOR

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.

Interventions

C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1.DEVICE

Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Tuttlingen, Germany) with blades Miller nr 0 and Miller nr 1.

Also known as: C-Mac Videolaryngoscope
VL-group
Direct laryngoscope with blades Miller nr 0 and Miller nr 1.DEVICE

Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1

Also known as: Standard direct laryngoscope
DL-group

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Riva T, Engelhardt T, Basciani R, Bonfiglio R, Cools E, Fuchs A, Garcia-Marcinkiewicz AG, Greif R, Habre W, Huber M, Petre MA, von Ungern-Sternberg BS, Sommerfield D, Theiler L, Disma N; OPTIMISE Collaboration. Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2023 Feb;7(2):101-111. doi: 10.1016/S2352-4642(22)00313-3. Epub 2022 Nov 24.

    PMID: 36436541DERIVED

Study Officials

  • Thomas Riva, MD

    University of Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 5, 2020

Study Start

April 1, 2020

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)