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Trial registered on ANZCTR


Registration number
ACTRN12614001134617
Ethics application status
Not yet submitted
Date submitted
15/09/2014
Date registered
24/10/2014
Date last updated
24/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Clinical Trial comparing C-MAC (Trademark) Videolaryngoscope Intubation with Direct Laryngoscope Intubation in Neonates. The HEADS UP Study
Scientific title
In neonates is intubation with videolaryngoscope superior to conventional laryngoscope for first attempt success.
Secondary ID [1] 285465 0
Nil
Universal Trial Number (UTN)
Trial acronym
The HEADS UP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endotracheal intubation in neonates. 293063 0
Condition category
Condition code
Reproductive Health and Childbirth 293336 293336 0 0
Complications of newborn
Respiratory 293337 293337 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290251 0
Treatment: Devices
Comparator / control treatment
Endotracheal intubation using standard laryngoscope Miller blade 0 or 1.
Control group
Active

Outcomes
Primary outcome [1] 293165 0
First attempt success rate. Intubation success is defined as endotracheal tube placement confirmed by end-tidal CO2 detection.
Timepoint [1] 293165 0
Primary outcome is assessed during intubation.
Secondary outcome [1] 310476 0
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.
Timepoint [1] 310476 0
During intubation.
Secondary outcome [2] 310477 0
The proportion of intubations occurring within 30second American Academy of Pediatric guidelines.
Timepoint [2] 310477 0
During intubation.
Secondary outcome [3] 310478 0
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.
Timepoint [3] 310478 0
During intubation.
Secondary outcome [4] 310479 0
Rate of complications related to intubation. Trauma to lips, gums, pharynx, lacerations or perforation.
Timepoint [4] 310479 0
After intubation.
Secondary outcome [5] 310480 0
Acceptability of the videplaryngoscope by the operator. Qualitative information will be recorded based on ease of use and view of glottis.
Timepoint [5] 310480 0
After intubation.

Eligibility
Key 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.
Minimum age
0 Hours
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The inclusion and exclusion criteria will be checked. The allocation will be concealed in sequentially numbered opaque envelopes. The most senior staff member will take the next sealed envelope to the delivery. Once it is known the baby will be intubated, the person performing the intubation will be decided upon, then the envelope will be opened to reveal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be by permuted block randomisation. It will be a stratified randomisation based on gestation to ensure the randomisation is evenly spread across gestation groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To the best of our knowledge there have been no randomised controlled trials assessing videolaryngoscope intubation at delivery or in a NICU on which to base a sample size on. This NICU does not have a record of intubation success rates from which a sample size can be calculated. In a previous published study by O’Donnell et al, during neonatal resuscitation using a standard laryngoscope, the overall success rate including all levels of experience, was 62%. If we base the sample size on these success rates and hope to improve first attempt success rates by 20% overall, to detect a difference between a rate of 55% in the direct intubation (control) group to 75% in the videolaryngoscope (intervention) group, 168 patients (84 in each group) will be required to achieve a power of 80% with a type 1 error rate of 5%. To detect an absolute difference of 20% and RRR 36.7%.
The demographic factors and clinical characteristics will be summarised with counts (percentages) for categorical variables, mean (standard deviation, SD) for normally distributed continuous variables or median (interquartile range, IQR or minimum-maximum) if the distribution is skewed.
The primary outcome, first time success (yes or no), will be analysed using logistic regression conducted within a generalised estimating equations (GEE) framework to account for the correlation in the data due to staff members performing more than one intubation. The outputs produced will be the odds ratio (95% confidence interval) and a p-value for the test that the odds ratio is different from 1. Pre-specified subgroups will be examined for the primary outcome: gestational age at time of intubation, weight at time of intubation (<1000g, 1001-1500g, 1501-2500g, >2500g), location at intubation (DS or NICU), premedication, nasal or oral tube insertion and level of experience of the person performing the intubation. This will be done to look at any difference in effect by these factors on success rate. The statistician will be blinded as to which group was the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2981 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8699 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 289952 0
Hospital
Name [1] 289952 0
Royal Prince Alfred Hospital
Department of Newborn Care
Country [1] 289952 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hosital, Department of Newborn Care
Address
Royal Prince Alfred Hospital
Missenden Road
Camperdown
2050
NSW
Country
Australia
Secondary sponsor category [1] 288642 0
None
Name [1] 288642 0
Address [1] 288642 0
Country [1] 288642 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291669 0
Sydney Local Health District
Ethics committee address [1] 291669 0
Ethics committee country [1] 291669 0
Australia
Date submitted for ethics approval [1] 291669 0
29/09/2014
Approval date [1] 291669 0
Ethics approval number [1] 291669 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51442 0
Dr Sarah Bellhouse
Address 51442 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 51442 0
Australia
Phone 51442 0
+61295158459
Fax 51442 0
Email 51442 0
Sarah.Bellhouse@sswahs.nsw.gov.au
Contact person for public queries
Name 51443 0
Sarah Bellhouse
Address 51443 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 51443 0
Australia
Phone 51443 0
+61295158459
Fax 51443 0
Email 51443 0
Sarah.Bellhouse@sswahs.nsw.gov.au
Contact person for scientific queries
Name 51444 0
Sarah Bellhouse
Address 51444 0
Department of Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 51444 0
Australia
Phone 51444 0
+61295158459
Fax 51444 0
Email 51444 0
Sarah.Bellhouse@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVideolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates.2018https://dx.doi.org/10.1002/14651858.CD009975.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.