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
c/o Vetenskapsrådet
BOX 1035
10138 Stockholm
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
Since caudal blocks produce a temporary rise in the intracranial pressure and lowers the central perfusion pressure of the brain we aim to verify if that contributes to ischemic signs on the EEG
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
Dr 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
Dr 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 individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
EEG registrations and excel sheet with NIRS, end-tidal Pco2, end-tidal Sevorane, and oxygen saturation Spo2
When will data be available (start and end dates)?
After publication of paper. No end date
Available to whom?
To whomever that want to seee/ verify data
Available for what types of analyses?
EEG interpretation
How or where can data be obtained?
by request to Paul Castillo
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6152Ethical approval  [email protected]
6153Study protocol  [email protected]



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.