Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001710112
Ethics application status
Approved
Date submitted
6/09/2019
Date registered
4/12/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Date results information initially provided
4/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of altitude on cerebral and splanchnic oxygen saturation in critically ill children during air ambulance transport
Scientific title
Influence of altitude on cerebral and splanchnic oxygen saturation in critically ill children during air ambulance transport
Secondary ID [1] 299203 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 314311 0
Condition category
Condition code
Respiratory 312661 312661 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cerebral and a splanchnic Near-infrared (NIRS) sensor were used to register regional oxygen saturation (rSO2) during transport of critically ill children in air ambulance. Participants were monitored for the entire flight with flights ranging from 60 minutes to 6 hours. The electronically stored data from the INVOS 5100C from 39 patients were afterwards extracted and examined to investigate how cerebral and splanchnic oxygen saturation was affected by flight with cabin pressurization corresponding to altitudes at 5000 feet or higher.
Intervention code [1] 315499 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321313 0
Number and percentage of patients with cerebral oxygen saturation levels effected 20% or more compared to ground levels. This is assessed by comparing cerebral NIRS values before flight, at sea level, with those during flight at altitude of 5000 feet or higher. Data are extracted from the NIRS monitor after the transport.
Timepoint [1] 321313 0
Direct after completion of patient transport
Primary outcome [2] 322157 0
The number and percentage of patients with splanchnic
oxygen saturation levels effected 20% or more compared to sea level. This is assesses by comparing splanchnic NIRS values before flight, at sea level, with those during flight at altitude of 5000 feet or higher. Data are extracted from the NIRS monitor after the transport.
Timepoint [2] 322157 0
Direct after completion of patient transport
Secondary outcome [1] 374598 0
Number and percentage of patients with cyanotic heart malformations who develop a difference of 20% or more in cerebral and splanchnic oxygen saturation during flight with cabin pressurization corresponding to 5000 feet or higher compared to levels at sea level. This is assesses by comparing NIRS values before flight, at sea level, with those during flight at altitude of 5000 feet or higher. Data are extracted from the NIRS monitor after the transport.
Timepoint [1] 374598 0
After collection of all patient data
Secondary outcome [2] 377531 0
Number and percentage of patients with non-cyanotic heart malformations who develop a difference of 20% or more in cerebral and splanchnic oxygen saturation during flight with cabin pressurization corresponding to 5000 feet or higher compared to levels at sea level. This is assesses by comparing NIRS values before flight, at sea level, with those during flight at altitude of 5000 feet or higher. Data are extracted from the NIRS monitor after the transport.
Timepoint [2] 377531 0
After collection of all patient data

Eligibility
Key inclusion criteria
Children scheduled for inter-hospital transport by a specialized pediatric transport team at the Pediatric Intensive Care Unit (PICU) at the Astrid Lindgren Children’s Hospital, Karolinska University Hospital in Stockholm, Sweden.
Minimum age
No limit
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Flights with an estimated duration less than 50 minutes and flights with a need for sea level cabin altitude. Lack of informed consent, participation in any other clinical research study,

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data is presented as median and inter-quartile range. The variability for rSO2-values are expressed by the coefficient of variation and compared with the Friedman’s test with the Dunn’s multiple comparison test. Wilcoxon signed-rank test is used for the comparison of column medians to a hypothetical value. Several independent populations are compared with Kruskal-Wallis statistics with the Dunn’s multiple comparison test.
All statistical tests were two sided and p values < 0.05 were considered to be statistically significant.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2014
Date of last participant enrolment
Anticipated
Actual
21/01/2019
Date of last data collection
Anticipated
Actual
22/01/2019
Sample size
Target
39
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 21837 0
Sweden
State/province [1] 21837 0

Funding & Sponsors
Funding source category [1] 303742 0
Government body
Name [1] 303742 0
Stockholms Läns Landsting. The County Council of Stockholm (Project 20150224)
Country [1] 303742 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Children's Hospital
Karolinska University Hospital Solna
S-171 76 Stockholm
Country
Sweden
Secondary sponsor category [1] 303862 0
Charities/Societies/Foundations
Name [1] 303862 0
Samariten foundation
Address [1] 303862 0
c/o Kristin Mattsson
Västra Vägen 23
169 61 Solna
Country [1] 303862 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304267 0
The Regional Ethical Review Board in Stockholm
Ethics committee address [1] 304267 0
Regionala etikprövningsnämnden i Stockholm
FE 289
171 77 STOCKHOLM
Ethics committee country [1] 304267 0
Sweden
Date submitted for ethics approval [1] 304267 0
29/08/2013
Approval date [1] 304267 0
25/09/2013
Ethics approval number [1] 304267 0
DNr 2013/1487-31/1 and 2016/2036-32

Summary
Brief summary
Near-infrared spectroscopy (NIRS) measures regional oxygen saturation (rSO2) of the underlying tissue. During air transport the effects of altitude on patient oxygenation are of special importance. With increasing altitude, barometric pressure decreases and as a result also the partial pressure of oxygen. The result is lower oxygen saturations. The primary aim of the current study is to investigate how cerebral and splanchnic oxygen saturation in critically ill children transported in air ambulance was affected by flight with cabin pressurization corresponding to 5000 feet or higher.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96346 0
Dr Tova Hannegård Hamrin
Address 96346 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 96346 0
Sweden
Phone 96346 0
+46704971513
Fax 96346 0
Email 96346 0
[email protected]
Contact person for public queries
Name 96347 0
Dr Tova Hannegård Hamrin
Address 96347 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 96347 0
Sweden
Phone 96347 0
+46704971513
Fax 96347 0
Email 96347 0
[email protected]
Contact person for scientific queries
Name 96348 0
Dr Tova Hannegård Hamrin
Address 96348 0
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 96348 0
Sweden
Phone 96348 0
+46704971513
Fax 96348 0
Email 96348 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4583Ethical approval    378322-(Uploaded-06-09-2019-20-18-57)-Study-related document.pdf
4584Informed consent form    378322-(Uploaded-28-11-2019-07-35-38)-Study-related document.doc
4620Study protocol    378322-(Uploaded-28-11-2019-07-55-08)-Study-related document.doc



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfluence of altitude on cerebral and splanchnic oxygen saturation in critically ill children during air ambulance transport.2020https://dx.doi.org/10.1371/journal.pone.0239272
N.B. These documents automatically identified may not have been verified by the study sponsor.