Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000420943
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
30/03/2020
Date last updated
30/03/2020
Date data sharing statement initially provided
30/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Electroencephalogram registration during caudal block for hernia repair in infants
Scientific title
EEG registration during caudal block for hernia repair in infants- in order to exclude signs of epilepsy or ischemia
Secondary ID [1] 299881 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caudal block anaesthesia 315297 0
hernia repair 315987 0
Condition category
Condition code
Anaesthesiology 313599 313599 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
EEG electrodes are connected to patients head with clay-like material to the patients that, regardless of the study should recieve a caudal block. After EEG is connected the caudal block is performed. The registration goes on until the surgery is finished or maximun 1 hour after the EEG registration started.
Intervention code [1] 316148 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322045 0
EEG signs of hypoxia
Timepoint [1] 322045 0
Within one hour post caudal block
Secondary outcome [1] 377140 0
EEG abnormalities such as epileptic signs on the EEG registration
Timepoint [1] 377140 0
Within one hour post caudal block
Secondary outcome [2] 377936 0
Near-infrared spectroscopy (NIRS) alteration; lowering of NIRS value
Timepoint [2] 377936 0
Within one hour post caudal block
Secondary outcome [3] 380968 0
End-tidal Pco2. Assessed from the ventilator. Value registred automatical during anaesthesia. No additional for this trial.
Timepoint [3] 380968 0
Within one hour after caudal block
Secondary outcome [4] 380969 0
End-tidal sevorane. Assessed from the ventilator. Value registred automatical during anaesthesia. No additional for this trial.
Timepoint [4] 380969 0
Within one hour post caudal block
Secondary outcome [5] 380970 0
Oxygen saturation Sa02.Assessed from the standars surveilance. . Value registred automatical during anaesthesia. No additional for this trial.
Timepoint [5] 380970 0
Within one hour post caudal block

Eligibility
Key inclusion criteria
Healthy infant 0-6 months who is undergoing hernia repair and has no contraindications for a caudal block.
The incuded patients will recieve a caudal block regardless of the study
Minimum age
No limit
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No parental conscent
Contraindications for caudal block

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
None planned

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
28/08/2020
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 22136 0
Sweden
State/province [1] 22136 0
Stockholm

Funding & Sponsors
Funding source category [1] 304339 0
Hospital
Name [1] 304339 0
Karolinska university
Country [1] 304339 0
Sweden
Primary sponsor type
Hospital
Name
Barn Perioperativ medicin och intensivvård ( Childrens Perioperative medicine and intensive care)
Address
Karolinska sjukhuset (Karolinska Hospital)
Eugeniavägen 23
17164 Solna
Country
Sweden
Secondary sponsor category [1] 304589 0
University
Name [1] 304589 0
Lars Falk, clinical director, Karolinska university hospital
Address [1] 304589 0
Karolinska university hospital Eugeniavägen 23 17164 Solna
Country [1] 304589 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304790 0
Central ethical review board (Centrala etiknämnden)
Ethics committee address [1] 304790 0
Ethics committee country [1] 304790 0
Sweden
Date submitted for ethics approval [1] 304790 0
14/03/2018
Approval date [1] 304790 0
23/04/2018
Ethics approval number [1] 304790 0
Ö9-2018

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

Contacts
Principal investigator
Name 98214 0
A/Prof Per Arne Lönnqvist
Address 98214 0
Karolinska university hospital Eugeniavägen 23 17164 Solna
Country 98214 0
Sweden
Phone 98214 0
+46707210650
Fax 98214 0
Email 98214 0
[email protected]
Contact person for public queries
Name 98215 0
Paul Castillo
Address 98215 0
Karolinska university hospital Eugeniavägen 23 17164 Solna
Country 98215 0
Sweden
Phone 98215 0
+46707524861
Fax 98215 0
Email 98215 0
[email protected]
Contact person for scientific queries
Name 98216 0
Paul Castillo
Address 98216 0
Karolinska university hospital Eugeniavägen 23 17164 Solna
Country 98216 0
Sweden
Phone 98216 0
+46707524861
Fax 98216 0
Email 98216 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• To whomever that want to seee/ verify data

Conditions for requesting access:
• -

What individual participant data might be shared?
• EEG registrations and excel sheet with NIRS, end-tidal Pco2, end-tidal Sevorane, and oxygen saturation Spo2

What types of analyses could be done with individual participant data?
• EEG interpretation

When can requests for individual participant data be made (start and end dates)?
From:
After publication of paper. No end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by request to Paul Castillo
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected]
Study protocol  [email protected]


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEEG response to a high volume (1.5 mL/kg) caudal block in infants less than 3 months.2023https://dx.doi.org/10.1136/rapm-2023-104452
N.B. These documents automatically identified may not have been verified by the study sponsor.