Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000895886
Ethics application status
Approved
Date submitted
21/08/2012
Date registered
22/08/2012
Date last updated
13/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Non invasive end tidal carbon dioxide monitoring study in patients presenting to the Emergency Department with an Acute Respiratory Illness: establishing whether there is a correlation between arterial blood gas and non-invasive monitored, carbon dioxide levels.
Scientific title
To determine whether we can substitute the invasive arterial blood gas measurement of CO2 with a non-invasive oral nasal cannula in patients presenting to the Emergency Department with acute respiratory illness
Secondary ID [1] 280941 0
Nil
Universal Trial Number (UTN)
Trial acronym
NIET-CO2 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Illness 287034 0
Condition category
Condition code
Respiratory 287361 287361 0 0
Chronic obstructive pulmonary disease
Respiratory 287362 287362 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Blood gas monitoring, especially carbon dioxide (CO2), is often needed for the appropriate management of patients with acute respiratory illnesses in the Emergency Department. Currently, the only accepted method to monitor CO2 is via arterial blood gas sample, however, repeated arterial blood sampling is invasive, causes patient discomfort, and fails to provide a continuous picture of changes in blood gas levels, in response to therapeutic interventions. Measuring oxygen saturation and carbon dioxide continuously provides more information about changes than single arterial measurements.

This study will monitor CO2, using a non-invasive oral nasal cannula attached to a monitor and compare this to the traditional arterial CO2 reading. A CO2 reading will be recorded at the same time that a blood gas is taken, to see if there is a correlation between non invasive CO2 (NIET-CO2) and ABG results. Each session will last approximately 15 minutes, and the patient may be involved in more than one session, if as part of their routine care they have more than one blood gas taken.
Intervention code [1] 285374 0
Not applicable
Comparator / control treatment
A CO2 reading will be recorded using a non-invasive oral nasal cannula attached to a monitor at the same time that a blood gas is taken, to see if there is a correlation between non invasive CO2 (NIET-CO2) and ABG CO2 results.
Control group
Active

Outcomes
Primary outcome [1] 287635 0
If there is a correlation between NIET-CO2 and ABG CO2 results.
Timepoint [1] 287635 0
non-invasive CO2 reading to be recorded at the same time as the arterial blood gas is taken, which could be at any time time during the course of treatment in the emergency department.
Secondary outcome [1] 298563 0
nil
Timepoint [1] 298563 0
nil

Eligibility
Key inclusion criteria
All patients with an acute respiratory illness who would normally have arterial blood gases done as part of their routine care will be deemed appropriate to be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age.
Pregnant patients (respiratory physiology changes considerably in pregnancy and may confound results)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2012
Actual
21/01/2013
Date of last participant enrolment
Anticipated
Actual
11/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
139
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285726 0
Charities/Societies/Foundations
Name [1] 285726 0
Fremantle Hospital Medical research Foundation
Country [1] 285726 0
Australia
Primary sponsor type
Individual
Name
Sarah Gow
Address
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country
Australia
Secondary sponsor category [1] 284554 0
Individual
Name [1] 284554 0
Yusuf Nagree
Address [1] 284554 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country [1] 284554 0
Australia
Other collaborator category [1] 276992 0
Individual
Name [1] 276992 0
Peter Sprivulis
Address [1] 276992 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country [1] 276992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287734 0
South Metropolitan Health Service HREC
Ethics committee address [1] 287734 0
Ethics committee country [1] 287734 0
Australia
Date submitted for ethics approval [1] 287734 0
17/07/2012
Approval date [1] 287734 0
14/08/2012
Ethics approval number [1] 287734 0
1/12/0240

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

Contacts
Principal investigator
Name 34510 0
Address 34510 0
Country 34510 0
Phone 34510 0
Fax 34510 0
Email 34510 0
Contact person for public queries
Name 17757 0
Sarah Gow
Address 17757 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country 17757 0
Australia
Phone 17757 0
+61 8 94313733
Fax 17757 0
+61 8 94313073
Email 17757 0
sarah.gow@health.wa.gov.au
Contact person for scientific queries
Name 8685 0
Sarah Gow
Address 8685 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country 8685 0
Australia
Phone 8685 0
+61 8 94313733
Fax 8685 0
+61 8 94313073
Email 8685 0
sarah.gow@health.wa.gov.au

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
No additional documents have been identified.