MedTrace Logo

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

NCT04295902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-03-09

No results posted yet for this study

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

Conditions

  • Airway Management

Interventions

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.

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

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • Gaslini Children's Hospital

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Montreal Children's Hospital of the MUHC

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Riva, MD · University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-03-08
Completion
2023-03-08

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295902 on ClinicalTrials.gov