Blood Gas AnalysisPhase 4NCT02516943
The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery
A Phase 4 study testing Guideline in people with Blood Gas Analysis, run by Mahidol University.
Trial summary
Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Gas Analysis
- What is being tested?
- Guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergone elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Emergency surgery
About this study
Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. We test the guideline for its safety and efficacy.
- Conditions
- Blood Gas Analysis
- Being tested
- Control, Guideline
- Keywords
- Arterial blood gas analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
The patient's ABGs were test according to a 4 - hour routine
GuidelineOther
The patient's ABGs were test according to the guideline for requests Arterial Blood Gas status post cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The patient were retrospectively included according to the last digit of their admission number (odd number). The had arterial blood gas analysis every 4 hour during the ICU stay. Receives: Other: Control |
| Guideline | Active comparator | The patient were prospectively included and they had arterial blood gas analysis following the pathological- based guidelines for arterial blood gas analysis in patients aftercardiac surgery Receives: Other: Guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ABG test
during intensive care stay
Measured: 14 days
Secondary outcomes (1)
Influence of ABG testing on patients' outcome.
during intensive care stay
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Gas AnalysisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516943
- Sponsor's protocol ID
- Si 723/2557(EC4)
- Status last verified
- Dec 2015
- First submitted
- 4 Aug 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery
- ClinicalTrials.gov ID
- NCT02516943
- Acronym / sponsor ID
- Si 723/2557(EC4)
- Conditions
- Blood Gas Analysis
- Keywords
- Arterial blood gas analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. We test the guideline for its safety and efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThe patient were retrospectively included according to the last digit of their admission number (odd number). The had arterial blood gas analysis every 4 hour during the ICU stay. |
| Guideline | Active comparator | Other: GuidelineThe patient were prospectively included and they had arterial blood gas analysis following the pathological- based guidelines for arterial blood gas analysis in patients aftercardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergone elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe patient's ABGs were test according to a 4 - hour routine | Other | Control |
| GuidelineThe patient's ABGs were test according to the guideline for requests Arterial Blood Gas status post cardiac surgery | Other | Guideline |
Primary outcome
Number of ABG test
Time frame: 14 days
during intensive care stay
1 secondary outcome
Influence of ABG testing on patients' outcome.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Suksompong, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guideline in people with Blood Gas Analysis, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ABG test (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.