Respiratory FailureNCT06522009
Effect of Time Delay and Syringe Surface Area on Blood Gas Samples Analysis
An observational study of Respiratory Failure, run by Helwan University at 1 site in Egypt.
Trial summary
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2019to 30 Jul 2020
- Phase
- Observational
- 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
Study population: Critically ill-patients, and intraoperative patients who aged above 18 years.
Who may be able to join
- Critically ill-patients, and intraoperative patients who aged above 18 years.
Who cannot join
- Patients with haematological diseases e.g. sickle cell anaemia
- burn patients with risk of carbon monoxide poisoning
- ARDS
- pulmonary oedema
- samples that were clotted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Time Delay and Syringe Surface Area on Results of Blood Gas Analysis
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes.
Read the detailed description
Arterial blood gas (ABG) analysis and monitoring is a crucial process for the diagnosis and management of the oxygenation status and acid-base balance of high-risk patients during surgery, as well as for the critical care of critically ill patients in the Intensive Care Unit .
Acid-base imbalance anomalies can have major repercussions in a number of medical scenarios, and in a few rare instances, they may even be a risk factor for death.
ABG test explores the arterial blood's pH, oxyhaemoglobin saturation (SaO2), bicarbonate concentration (HCO3), oxygen tension (PaO2), and carbon dioxide tension (PaCO2).
Traditionally, the concept "blood gas testing" has been used to describe measuring the blood's pH, oxygen saturation of haemoglobin (SaO2), and partial pressures of the physiologically active gases (pO2, pCO2). But now available commercial equipment can measure electrolytes (sodium, potassium, chloride, ionized calcium, and magnesium), glucose, lactate, and creatinine, usually all at the same time, in addition to haemoglobin quantification and co-oximetry
- Conditions
- Respiratory Failure
- Keywords
- blood gas, oxygen saturation, syringe surface area, Time Delay
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2) arterial and venous blood gas outcomes.
PaO2 by mmhg arterial and venous samples
To detect the effect of time delay and syringe surface area on SO2 in arterial and venous samples
To detect the effect of time delay and syringe surface area on other parameters of blood gases e.g. PH,CO2
Measured: 1 hour
Secondary outcomes (1)
effect of delay on analysis oxyhaemoglobin saturation (SaO2) acidity (pH) carbon dioxide tension (PaCO2)
spao2 by mmhg and paco2 by mmhg
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Jul 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Responsible party
- Principal investigator, Adel Ali Hassan, Helwan University
- Investigators
- Adel A hassan, Md, Principal investigator, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522009
- Sponsor's protocol ID
- 19/4/471
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time Delay and Syringe Surface Area on Results of Blood Gas Analysis
- ClinicalTrials.gov ID
- NCT06522009
- Acronym / sponsor ID
- 19/4/471
- Conditions
- Respiratory Failure
- Keywords
- blood gas, oxygen saturation, syringe surface area, Time Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 26 Jul 2024 (actual)
- 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.
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes.
Detailed description
Arterial blood gas (ABG) analysis and monitoring is a crucial process for the diagnosis and management of the oxygenation status and acid-base balance of high-risk patients during surgery, as well as for the critical care of critically ill patients in the Intensive Care Unit .
Acid-base imbalance anomalies can have major repercussions in a number of medical scenarios, and in a few rare instances, they may even be a risk factor for death.
ABG test explores the arterial blood's pH, oxyhaemoglobin saturation (SaO2), bicarbonate concentration (HCO3), oxygen tension (PaO2), and carbon dioxide tension (PaCO2).
Traditionally, the concept "blood gas testing" has been used to describe measuring the blood's pH, oxygen saturation of haemoglobin (SaO2), and partial pressures of the physiologically active gases (pO2, pCO2). But now available commercial equipment can measure electrolytes (sodium, potassium, chloride, ionized calcium, and magnesium), glucose, lactate, and creatinine, usually all at the same time, in addition to haemoglobin quantification and co-oximetry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill-patients, and intraoperative patients who aged above 18 years.
Key inclusion criteria (1 listed)
- Critically ill-patients, and intraoperative patients who aged above 18 years.
Key exclusion criteria (5 listed)
- Patients with haematological diseases e.g. sickle cell anaemia
- burn patients with risk of carbon monoxide poisoning
- ARDS
- pulmonary oedema
- samples that were clotted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2) arterial and venous blood gas outcomes.
Time frame: 1 hour
PaO2 by mmhg arterial and venous samples To detect the effect of time delay and syringe surface area on SO2 in arterial and venous samples To detect the effect of time delay and syringe surface area on other parameters of blood gases e.g. PH,CO2
1 secondary outcome
effect of delay on analysis oxyhaemoglobin saturation (SaO2) acidity (pH) carbon dioxide tension (PaCO2)
Time frame: 60 minutes
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 9 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
Adel A hassan, Md principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Helwan University at 1 site in Egypt.
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 5 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2) arterial and venous blood gas outcomes. (time frame: 1 hour). 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 9 Aug 2024.