Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000750381
Ethics application status
Approved
Date submitted
3/05/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring tissue oxygenation by near-infrared spectroscopy (NIRS) in air ambulance transports of critically ill children – a methodological study
Scientific title
Monitoring tissue oxygenation by near-infrared spectroscopy (NIRS) in air ambulance transports of critically ill children – a methodological study
Secondary ID [1] 291752 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 302972 0
Condition category
Condition code
Other 302439 302439 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this methodological study, a cerebral and a somatic (abdominal) Near-infrared (NIRS) sensor were used to register regional oxygen saturation (rSO2) during planned and acute transports of critically ill patients to and from the PICU of a tertiary university hospital Patients (n=38) were transported in air ambulance and connecting ground ambulance (convenience sampling) by a pedaitric specialized transport team. The electronically stored data from the INVOS 5100C was afterwards extracted and examined. In order to reduce as much noise as possible in the NIRS-signal without improperly busting the underlying information the signal was smoothed by using the Savitzky-Golay filtering method. The duration for which the NIRS monitoring took place was from time of departure to arrival at hospital site in all patients. If patients were monitored due to clinical considerations in the PICU before time of departure, this data was also analyzed.
Intervention code [1] 297865 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301848 0
% of reliable NIRS measurements with cerebral and somatic NIRS monitoring during pediatric transport in air ambulance and connecting road ambulance.
Timepoint [1] 301848 0
Direct after completion of patient transport
Secondary outcome [1] 334037 0
Quality of NIRS signal data assessed using the Savitzky-Golay filtering algorithm.
Timepoint [1] 334037 0
In direct connection to the completion of the patient transport

Eligibility
Key inclusion criteria
Children transported on an inter-hospital transfer by the specialized pediatric transport team at the Pediatric Intensive Care Unit (PICU) at the Astrid Lindgren Children’s Hospital, Karolinska University Hospital in Stockholm
Minimum age
No limit
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of informed consent or participation in any other clinical research study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data was presented as median and inter-quartile range.
The NIRS curves were smoothed by the Savitzky-Golay filtering method.
The noise of the NIRS curves was defined as the median value of the absolute differences of all adjacent data points.
Mann-Whitney U-test was used for the comparison of data from two independent populations. Several independent populations were compared with the Kruskal-Wallis test with Dunn's multiple comparison test.
Wilcoxon matched-pairs signed-ranks test was used for comparison of two related populations.
Several related populations were compared with the Friedman test with Dunn's multiple comparison test.
Correlations were established by the Spearman rank correlation test.
All statistical tests were two-sided and p-values less than 0.05 were considered to be statistical significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2014
Date of last participant enrolment
Anticipated
Actual
28/09/2016
Date of last data collection
Anticipated
Actual
28/09/2016
Sample size
Target
38
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 8836 0
Sweden
State/province [1] 8836 0

Funding & Sponsors
Funding source category [1] 296250 0
Government body
Name [1] 296250 0
Stockholms Lans Landsting. The County Council of Stockholm (Project 20130324)
Country [1] 296250 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 295165 0
Individual
Name [1] 295165 0
Jonas Berner
Address [1] 295165 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country [1] 295165 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297488 0
The Regional Ethical Review Board in Stockholm
Ethics committee address [1] 297488 0
Regionala etikprovningsnamnden i Stockholm
FE 289
171 77 STOCKHOLM
Ethics committee country [1] 297488 0
Sweden
Date submitted for ethics approval [1] 297488 0
29/08/2013
Approval date [1] 297488 0
25/09/2013
Ethics approval number [1] 297488 0
2013/1487-31/1 and 2016/2036-32

Summary
Brief summary
Near-infrared spectroscopy (NIRS) measures regional oxygen saturation (rSO2) of the underlying tissue and may be a useful additional monitoring tool to already existing medical monitoring equipment during inter-hospital transports. Values are usually read using real time monitor readings on-line, but real-time readings are sometimes unreliable during transport. NIRS data can also be electronically stored by the monitor, for example during the period of transport, and extracted and examined afterwards. However the electronically stored data is associated with a high degree of noise in the signal. The aim of the present study was to investigate how monitoring with near-infrared spectroscopy (NIRS) during pediatric air ambulance transports can be optimized by processing of the electronically stored data using a mathematical algorithm to reduce as much noise as possible in the signal without improperly busting the underlying information,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74198 0
Dr Tova Hannegard Hamrin
Address 74198 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 74198 0
Sweden
Phone 74198 0
+46704971513
Fax 74198 0
Email 74198 0
[email protected]
Contact person for public queries
Name 74199 0
Tova Hannegard Hamrin
Address 74199 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 74199 0
Sweden
Phone 74199 0
+46851778285
Fax 74199 0
Email 74199 0
[email protected]
Contact person for scientific queries
Name 74200 0
Tova Hannegard Hamrin
Address 74200 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 74200 0
Sweden
Phone 74200 0
+46851778285
Fax 74200 0
Email 74200 0
[email protected]

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
EmbasePerformance of regional oxygen saturation monitoring by near-infrared spectroscopy (NIRS) in pediatric inter-hospital transports with special reference to air ambulance transports: a methodological study.2018https://dx.doi.org/10.1007/s10877-017-0094-z
N.B. These documents automatically identified may not have been verified by the study sponsor.