Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06683599




Registration number
NCT06683599
Ethics application status
Date submitted
5/11/2024
Date registered
12/11/2024

Titles & IDs
Public title
LaryngOscoPy for neonaTal and Infant aIrway Management wIth Supplemental oxygEn
Scientific title
LaryngOscoPy for neonaTal and Infant aIrway Management wIth Supplemental oxygEn (OPTIMISE-3): a Multi-center, Prospective Randomized Controlled Trial
Secondary ID [1] 0 0
OPTIMISE-3
Universal Trial Number (UTN)
Trial acronym
OPTIMISE-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Airway 0 0
Difficult Airway Intubation 0 0
Neonate 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Apneic oxygenation

No intervention: Standard of care - Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation.

Experimental: Apneic oxygenation - 1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.


Treatment: Surgery: Apneic oxygenation
1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First-attempt success rate
Timepoint [1] 0 0
From randomization until up to 15 minutes
Secondary outcome [1] 0 0
Desaturation rate
Timepoint [1] 0 0
From randomization until up to 15 minutes
Secondary outcome [2] 0 0
Overall number of intubation attempts
Timepoint [2] 0 0
From randomization until up to 15 minutes
Secondary outcome [3] 0 0
Time to intubation
Timepoint [3] 0 0
From randomization until up to 5 minutes
Secondary outcome [4] 0 0
Respiratory complications rate
Timepoint [4] 0 0
From randomization until up to 24 hours
Secondary outcome [5] 0 0
First EtCO2 after successful intubation
Timepoint [5] 0 0
From randomization until up to 10 minutes
Secondary outcome [6] 0 0
Cormack-Lehane score
Timepoint [6] 0 0
From randomization until up to 5 minutes
Secondary outcome [7] 0 0
The need for additional devices
Timepoint [7] 0 0
From randomization until up to 5 minutes
Secondary outcome [8] 0 0
Duration of severe desaturation
Timepoint [8] 0 0
From randomization until up to 15 minutes
Secondary outcome [9] 0 0
Percentage of Glottic Opening (POGO) score
Timepoint [9] 0 0
From randomization until up to 5 minutes

Eligibility
Key inclusion criteria
* Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.
* Neonates and infants up to 52 weeks post-conceptual age.
* Written informed consent provided by legal guardians prior to the intervention.
Minimum age
1 Minute
Maximum age
52 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
* Requirement for an alternative technique to direct laryngoscopy to secure the airway.
* Specific conditions, such as congenital heart disease requiring FiO2 < 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo

Funding & Sponsors
Primary sponsor type
Other
Name
Vinícius C Quintão, MD, MSc, PhD
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Bern
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Western Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vinicius C Quintao, MD, MSc, PhD
Address 0 0
Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vinicius C Quintao, MD, MSc, PhD
Address 0 0
Country 0 0
Phone 0 0
+ 55 11 97127-3950
Fax 0 0
Email 0 0
vinicius.quintao@hc.fm.usp.br
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06683599