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A Randomised Controlled Clinical Trial comparing C-MAC (Trademark) Videolaryngoscope Intubation with Direct Laryngoscope Intubation in Neonates. The HEADS UP Study

In neonates is intubation with videolaryngoscope superior to conventional laryngoscope for first attempt success.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001134617
Acronym
The HEADS UP Study
Enrollment
170
Registered
2014-10-24
Start date
2015-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

When a neonate requires intubating it needs to occur quickly. Successful intubation can be challenging in small infants. It entails visualization of the glottis followed by insertion of the endotracheal tube through the cords, in a timely manner with minimal compromise to the infant. The current method is to use a laryngoscope to allow direct vision of the vocal cords. Direct vision requires a line of sight along the laryngoscope blade with a light source to view the vocal cords. In the neonate achieving a good view can be a challenge. The videolaryngoscope enables an excellent view of the glottis and its use has been widely studied in adults and paediatric surgical patients. Although many neonatal intensive care units (NICU’s) have integrated the use of this tool into standard care, there is limited evidence for its’ use in neonates. Intubation is a specialised skill and takes time to learn. The more attempts and longer it takes to intubate can potentially impact on an infant due to hypoxia or local trauma. We need to expand our knowledge of the safety of this instrument in acute neonatal care, value in the usefulness of the tool and determine its potential for teaching. If the videolaryngoscope is superior to the standard method, then its use may become even more widely implemented.

Interventions

Endotracheal intubation using Storz C-MAC (Trademark) Videolaryngoscope Miller blade size 0 or 1. The C-MAC has a tiny digital video camera and light source built into the tip of the blade and handle, allowing indirect vision of the glottis. The camera enables a magnified image to be displayed on a small monitor. The operator keeps their head up watching the monitor during the intubation procedure. Duration times for intubation vary from between 20-60secs.

Sponsors

Royal Prince Alfred Hosital, Department of Newborn Care
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
0 to 6 Months
Healthy volunteers
No

Inclusion criteria

Babies born at 24 completed weeks gestation and above, and require endotracheal intubation in the delivery room or delivery theatre. Infants requiring endotracheal intubation in the neonatal intensive care unit.

Exclusion criteria

Infants with major oral or upper airway malformation will be excluded from the analysis. Any emergency intubation where there is insufficient time to prepare the videolaryngoscope. Any emergency intubation without sufficient time to prepare randomisation. Babies <24 weeks gestation at the time of intubation due to limitation of blade size.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026