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NCT05967507 · ClinicalTrials.gov registry record · NA

Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)

A NA study, sponsored by Thomas Riva.

Recruiting
Registry status
NA
Development phase
1,192
Enrollment target

NCT05967507: Recruiting NA study, sponsored by Thomas Riva.

NCT05967507 is a NA study that is actively recruiting participants, run by Thomas Riva. The registered enrollment target is 1,192 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05967507, a NA study, is actively recruiting participants, sponsored by Thomas Riva.

RECRUITING
Registry status
NA
Development phase
1,192 participants
Enrollment target

Study Summary

This study aims to investigate the optimal oxygen flow rate needed during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) using Miller-blade or Macintosh-blade size No. 0 or No. 1 in the operating room or intensive care unit. The investigators hypothesize that the difference between low-flow and high-flow supplemental oxygen is negligible.

Primary Outcome

The primary study outcome is to evaluate the first attempt success rate of oral and nasal tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with supplemental oxygen with low-flow vs high flow among neonates and infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography sugg

Interventions

  • DEVICE Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope
  • DEVICE High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope

Trial Details

FieldValue
Enrollment Target 1,192 participants
Start Date 2023-12-01
Est. Completion 2027-09
Phase NA
Thomas Riva

2 total trials

What NCT05967507 shows while recruiting

NCT05967507 is an interventional study that assigns participants to a tested intervention. Its 1,192 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (15% lower).

The record links to 0 conditions, and to 2 interventions - of which Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope is the first listed.

NCT05967507 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05967507 about?

NCT05967507 is a clinical study titled "Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)". This study aims to investigate the optimal oxygen flow rate needed during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) using Miller-blade or Macintosh-blade size No. 0 or No. 1 in the operating room or intensive care unit. The investigators hypothesize that...

What is the current status of trial NCT05967507?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,192 participants. The study started on 2023-12-01. Estimated completion is 2027-09.

What interventions are being tested in trial NCT05967507?

The interventions under investigation include: Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope (DEVICE), High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope (DEVICE).

Who is sponsoring clinical trial NCT05967507?

This trial is sponsored by Thomas Riva, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05967507's enrollment target sits among peer trials

1,192 89th of 2000 higher than 1,912 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05967507, the US trial registry maintained by the National Library of Medicine. NCT05967507 (large enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.