Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

NCT04994652 | Completed

• 1 other identifier: VODE01
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal intubation is a critical intervention for newborn babies. Laryngoscopy is the crucial part of endotracheal intubation. Traditionally, operators use a standard laryngoscope to view the larynx by looking directly into the mouth (direct laryngoscopy). More recently videolaryngoscopes that have a video camera mounted at the tip of the laryngoscope blade have been developed, Rather than look directly into the mouth, the operator looks at a screen that displays the view acquired by the camera (indirect laryngoscopy). Videolaryngoscopes have been demonstrated to be useful for teaching trainees direct laryngoscopy. However, it may be that all clinicians are more successful with a videolaryngoscope. The investigators will compare whether clinicians who are randomly assigned to intubate newborn infants using a videolaryngoscope are more successful in intubating newborn infants at the first attempt compared to clinicians who are randomly assigned to intubate newborn infants using a standard laryngoscope.

Conditions

Intubation, Intratracheal; Infant, Newborn; Laryngoscopes

Outcome Measures

Primary Outcomes (1)

• Intubation success at first attempt

  Endotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor

  5 minutes

Secondary Outcomes (6)

• Lowest SpO2 during first intubation attempt

  5 minutes

• Lowest HR during first intubation attempt

  5 minutes

• Number of attempts taken to intubate successfully

  30 minutes

• Duration of successful attempt

  30 minutes

• Crossover to alternative device

  30 minutes

Study Arms (2)

Videolaryngoscope

EXPERIMENTAL

Intubation attempted with C-MAC videolaryngoscope

Device: Videolaryngoscopy

Standard laryngoscope

ACTIVE COMPARATOR

Intubation attempted with standard laryngoscope

Device: Direct laryngoscopy

Interventions

Videolaryngoscopy DEVICE

Indirect laryngoscopy using the C-MAC videolaryngoscope

Videolaryngoscope

Direct laryngoscopy DEVICE

Direct laryngoscopy with a standard laryngoscope

Standard laryngoscope

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants (term and preterm, of any gender) in whom endotracheal intubation is attempted in the course of their clinical care in the Delivery Room or Neonatal Intensive Care Unit.

You may not qualify if:

• Infants with upper airway anomalies

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

National Maternity Hospital

Dublin, Co. Dublin, D02 YH21, Ireland

Location

Related Publications (1)

• Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.

  PMID: 38709215 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, randomised clinical trial

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 6, 2021
• Study Start: September 4, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 20, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

IE (1)