ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical illness

Condition category

Condition code

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Direct after completion of patient transport

Primary outcome [2]

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]

Direct after completion of patient transport

Secondary outcome [1]

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]

After collection of all patient data

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sweden

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Stockholms Läns Landsting. The County Council of Stockholm (Project 20150224)

Address [1]

FoUU-enheten
Karolinska Universitetssjukhuset
171 76 Stockholm

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Samariten foundation

Address [1]

c/o Kristin Mattsson
Västra Vägen 23
169 61 Solna

Country [1]

Sweden

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Regional Ethical Review Board in Stockholm

Ethics committee address [1]

Regionala etikprövningsnämnden i Stockholm
FE 289
171 77 STOCKHOLM

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

29/08/2013

Approval date [1]

25/09/2013

Ethics approval number [1]

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

Dr Tova Hannegård Hamrin

Address

Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm

Country

Sweden

Phone

+46704971513

Fax

[email protected]

Contact person for public queries

Name

Tova Hannegård Hamrin

Address

Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm

Country

Sweden

Phone

+46704971513

Fax

[email protected]

Contact person for scientific queries

Name

Tova Hannegård Hamrin

Address

Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm

Country

Sweden

Phone

+46704971513

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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

Source	Title	Year of Publication	DOI
Embase	Influence of altitude on cerebral and splanchnic oxygen saturation in critically ill children during air ambulance transport.	2020	https://dx.doi.org/10.1371/journal.pone.0239272

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically