A Randomised Controlled Clinical Trial comparing C-MAC (Trademark) Videolaryngoscope Intubation with Direct Laryngoscope Intubation in Neonates. The HEADS UP Study
Not Applicable
- Conditions
- Endotracheal intubation in neonates.Reproductive Health and Childbirth - Complications of newbornRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12614001134617
- Lead Sponsor
- Royal Prince Alfred Hosital, Department of Newborn Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 170
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First attempt success rate. Intubation success is defined as endotracheal tube placement confirmed by end-tidal CO2 detection.[Primary outcome is assessed during intubation.]
- Secondary Outcome Measures
Name Time Method Duration of intubation attempt. Defined as the time from when the laryngoscope blade passes the lips until it is removed and intubation is either successful or abandoned and infant returned to mask ventilation.[During intubation.];The proportion of intubations occurring within 30second American Academy of Pediatric guidelines.[During intubation.];Stability of infant during the intubation. Measured by the length of time of hypoxia, based on infants saturations and heart rate. Infants will be monitored by use of Massimo pulse oximeter and ECG chest leads.[During intubation.];Rate of complications related to intubation. Trauma to lips, gums, pharynx, lacerations or perforation.[After intubation.];Acceptability of the videplaryngoscope by the operator. Qualitative information will be recorded based on ease of use and view of glottis. [After intubation.]