DyspneaNCT04409470
Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients
An observational study of Dyspnea and Hypercapnia, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
In the emergency department and intensive care unit, blood gas analysis is a crucial tool in the assessment of critically ill patients. Blood gas analysis is quick and repeatable at the bedside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Hypercapnia
- What is being tested?
- Blood gas sampling from artery and vein
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 11 Oct 2021to 27 Mar 2022
- 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
- Adult, Older adult
Study population: For enrolment, we will consider all patients who are admitted to the emergency department irrespective of mode of arrival (ambulance, walk-in etc). To be eligible, patients will need to be classified as critical ill and there has to be a clear clinical indication for an arterial blood gas sampling. Indications for arterial blood gas sampling, in turn, are primarily dictated by local SOPs (Standard Operating Procedures; "PM/ vårdprocessåtgärder") for appropriate sampling based on chief complaint, age, and vital signs upon arrival. The aim is to include these patients consecutively around-the-clock.
Who may be able to join
- Patients able to understand and process oral and written information and give his/her consent (within 12h), or consent provided by a close relative.
- Aged > 18 years
- Assessed to be in need of arterial blood gas analysis
Who cannot join
- Unwilling to participate, or unable to understand the provided information
- Inability to give subsequently consent (> 12 hours) or unwillingness by close relative to provide consent.
- Pregnant
- Aged < 18 years
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital Linköping
Linköping, Östergötland County, 58185
About this study
In the emergency department and intensive care unit, blood gas analysis is a crucial tool in the assessment of critically ill patients. Blood gas analysis is quick and repeatable at the bedside. The sampling can be done from both arterial and venous samples, with arterial samples generally considered to be more reliable and by that widely used as the standard method.
The purpose of this project is to compare venous and arterial blood gas parameters in undifferentiated, critically ill patients. We plan to evaluate the correlation between different parameters through a prospective observational study. In particular, carbon dioxide partial pressure (pCO2) correlation between venous and arterial samples is investigated by using and comparing different conversion models proposed in the literature.
Read more
250 patients deemed to be in need of arterial blood gas sampling based on their clinical condition will be included in a consecutive fashion at all hours.
The long-term goal is to clinically translate the findings into a limitation on the use of arterial sampling, which could potentially reduce pain and complication risks in the many patients who undergo arterial blood gas sampling every day.
Read the detailed description
== Practical procedures \& flowchart ==
Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.
Sampling can be carried out by doctors or nurses. The arterial and venous blood gas analysis is performed with a blood gas analyzer (ABL90) in the emergency department and is performed immediately after the sampling. Sampling times and analysis times are documented.
Survey results are routinely stored in electronic form in patient health record and also locally on the device ABL90 with social security number as ID. The data is saved for statistical analysis.
== Documentation ==
The following parameters are documented during sampling:
- Chief complaint
- Indication for sampling
- The patient's current vital signs at the time of sampling
- Ongoing oxygen treatment (flow rate)
- Size of cannula, sampling location
- Sampling times and analysis times
- Number of puncture attempts
After sampling, the following is documented:
- Analysis results of venous and arterial blood gas sample
- Final diagnosis at discharge from the emergency department
The documentation will primarily be on worksheets, which will be marked with a patient label (name / social security number) and a serial number. The worksheet will be stored together with consent forms in a locked space of Akutkliniken US Linköping.
The data will be archived in the local emergency department or at the Regional Archives in Östergötland according to applicable laws and regulations.
The result of blood gas analysis is obtained from the digital lab system in the patient record (Lab-ROS) or directly exported from the internal memory of the analyzers at the emergency department. In both cases, the results will be used for digital compilation of study data. All electronic storage of study data will be pseudonymized by linking to patients serial number.
== Statistics ==
In previous studies, the correlation between arterial and venous samples has been evaluated using several different statistical methods:
- T-test, Pearson's and Spearman's R variable
- Descriptive data are presented as mean and +/- from SD
Our intention in this study is to make a parallel comparison of previously published methods, as well as to examine, based on collected data, whether a new formula with better precision can be derived.
== The potential significance of the project ==
At present, arterial blood gas sampling is used as the standard procedure for assessing a critically ill patient in the emergency department.
The project aims to clarify the feasibility of replacing routine arterial blood gas sampling in the emergency department with venous punctures without impairing test results and patient care. If feasible, such a change in sampling routines could potentially mean a great improvement for patients in terms of pain and complication risks. Also, workflow and lead times in the emergency department could be improved by the fact that venous samples may be drawn by all clinical staff, whereas arterial samples are normally reserved for doctors and nurses with dedicated training.
- Conditions
- Dyspnea, Hypercapnia
- Being tested
- Blood gas sampling from artery and vein
- Keywords
- arterial blood gas, venous blood gas
- Medical subject headings
- Dyspnea, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood gas sampling from artery and veinDiagnostic test
Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.
| Study group | Role | What they receive |
|---|---|---|
| Indication for blood gas sampling | To be eligible, patients will need to be classified as critically ill and there has to be a clear clinical indication for an arterial blood gas sampling. Enrollment will be performed in a consecutive manner at all hours. Receives: Diagnostic Test: Blood gas sampling from artery and vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
How does pCO2 correlate between arterial and venous blood gas samples?
Measured: October - November 2020
Can a clinically reliable correlation be identified using a conversion model? (existing or new)
Measured: October - November 2020
Secondary outcomes (4)
How does processing times and sampling location affect the result?
Measured: October - November 2020
How does the patient's vital parameters (blood pressure, pulse) affect the results?
Measured: October - November 2020
In there a difference in the analysis results between the emergency department and the central laboratory?
Measured: October - November 2020
How reliable are the results beyond mild to moderate deviations from normal values in consecutive enrolled, critically ill patients?
Measured: October - November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start11 Oct 2021
- Primary completion27 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Matthias Jörg, MD, Principal investigator, Emergency Department, University Hospital Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409470
- Sponsor's protocol ID
- SE2020-00396
- Status last verified
- Jun 2022
- First submitted
- 26 May 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bengezi OA, Dalcin A, Al-Thani H, Bain JR. Unusual complication of radial artery cannulation. Can J Plast Surg. 2003 Winter;11(4):213-5. doi: 10.1177/229255030301100409.
PubMed 24009442Bloom BM, Grundlingh J, Bestwick JP, Harris T. The role of venous blood gas in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2014 Apr;21(2):81-8. doi: 10.1097/MEJ.0b013e32836437cf.
PubMed 23903783EMCrit, About, Josh Farkas, and The Emcrit Crew. 2017. "PulmCrit- How to Convert a VBG into an ABG." EMCrit Project. January 16, 2017. https://emcrit.org/pulmcrit/vbg-abg/.
Giner J, Casan P, Belda J, Litvan H, Sanchis J. [Use of the anesthetic cream EMLA in arterial punction]. Rev Esp Anestesiol Reanim. 2000 Feb;47(2):63-6. Spanish.
PubMed 10769553Hess D, Agarwal NN. Variability of blood gases, pulse oximeter saturation, and end-tidal carbon dioxide pressure in stable, mechanically ventilated trauma patients. J Clin Monit. 1992 Apr;8(2):111-5. doi: 10.1007/BF01617428.
PubMed 1583545Jang JS, Jin HY, Seo JS, Yang TH, Kim DK, Kim DK, Kim DI, Cho KI, Kim BH, Park YH, Je HG, Kim DS. The transradial versus the transfemoral approach for primary percutaneous coronary intervention in patients with acute myocardial infarction: a systematic review and meta-analysis. EuroIntervention. 2012 Aug;8(4):501-10. doi: 10.4244/EIJV8I4A78.
PubMed 22581470Kelly AM, McAlpine R, Kyle E. How accurate are pulse oximeters in patients with acute exacerbations of chronic obstructive airways disease? Respir Med. 2001 May;95(5):336-40. doi: 10.1053/rmed.2001.1046.
PubMed 11392573Kelly AM. Can VBG analysis replace ABG analysis in emergency care? Emerg Med J. 2016 Feb;33(2):152-4. doi: 10.1136/emermed-2014-204326. Epub 2014 Dec 31.
PubMed 25552544Lemoel F, Govciyan S, El Omri M, Marquette CH, Levraut J. Improving the validity of peripheral venous blood gas analysis as an estimate of arterial blood gas by correcting the venous values with SvO(2). J Emerg Med. 2013 Mar;44(3):709-16. doi: 10.1016/j.jemermed.2012.07.041. Epub 2012 Aug 24.
PubMed 22921853Malatesha G, Singh NK, Bharija A, Rehani B, Goel A. Comparison of arterial and venous pH, bicarbonate, PCO2 and PO2 in initial emergency department assessment. Emerg Med J. 2007 Aug;24(8):569-71. doi: 10.1136/emj.2007.046979.
PubMed 17652681O'Connor TM, Barry PJ, Jahangir A, Finn C, Buckley BM, El-Gammal A. Comparison of arterial and venous blood gases and the effects of analysis delay and air contamination on arterial samples in patients with chronic obstructive pulmonary disease and healthy controls. Respiration. 2011;81(1):18-25. doi: 10.1159/000281879. Epub 2010 Feb 4.
PubMed 20134147Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
PubMed 12133178Shah, Shobhit, and Department of Medicine and Pulmonology, Mata Chanan Devi Hospital, Janakpuri, New Delhi. 2017. "Comparison and Agreement between Venous and Arterial Blood Gas Values for pH, pCO2, pO2, Bicarbonate and Oxygen Saturation in Patients with Acute Respiratory Illnesses." Journal of Medical Science And Clinical Research 05 (03):19069-70.
Shirani F, Salehi R, Naini AE, Azizkhani R, Gholamrezaei A. The effects of hypotension on differences between the results of simultaneous venous and arterial blood gas analysis. J Res Med Sci. 2011 Feb;16(2):188-94.
PubMed 22091230Thorson SH, Marini JJ, Pierson DJ, Hudson LD. Variability of arterial blood gas values in stable patients in the ICU. Chest. 1983 Jul;84(1):14-8. doi: 10.1378/chest.84.1.14.
PubMed 6407807
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients
- ClinicalTrials.gov ID
- NCT04409470
- Acronym / sponsor ID
- SE2020-00396
- Conditions
- Dyspnea, Hypercapnia
- Keywords
- arterial blood gas, venous blood gas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 1 Jun 2020 (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.
In the emergency department and intensive care unit, blood gas analysis is a crucial tool in the assessment of critically ill patients. Blood gas analysis is quick and repeatable at the bedside. The sampling can be done from both arterial and venous samples, with arterial samples generally considered to be more reliable and by that widely used as the standard method.
The purpose of this project is to compare venous and arterial blood gas parameters in undifferentiated, critically ill patients. We plan to evaluate the correlation between different parameters through a prospective observational study. In particular, carbon dioxide partial pressure (pCO2) correlation between venous and arterial samples is investigated by using and comparing different conversion models proposed in the literature.
250 patients deemed to be in need of arterial blood gas sampling based on their clinical condition will be included in a consecutive fashion at all hours.
The long-term goal is to clinically translate the findings into a limitation on the use of arterial sampling, which could potentially reduce pain and complication risks in the many patients who undergo arterial blood gas sampling every day.
Detailed description
== Practical procedures \& flowchart ==
Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.
Sampling can be carried out by doctors or nurses. The arterial and venous blood gas analysis is performed with a blood gas analyzer (ABL90) in the emergency department and is performed immediately after the sampling. Sampling times and analysis times are documented.
Survey results are routinely stored in electronic form in patient health record and also locally on the device ABL90 with social security number as ID. The data is saved for statistical analysis.
== Documentation ==
The following parameters are documented during sampling:
- Chief complaint
- Indication for sampling
- The patient's current vital signs at the time of sampling
- Ongoing oxygen treatment (flow rate)
- Size of cannula, sampling location
- Sampling times and analysis times
- Number of puncture attempts
After sampling, the following is documented:
- Analysis results of venous and arterial blood gas sample
- Final diagnosis at discharge from the emergency department
The documentation will primarily be on worksheets, which will be marked with a patient label (name / social security number) and a serial number. The worksheet will be stored together with consent forms in a locked space of Akutkliniken US Linköping.
The data will be archived in the local emergency department or at the Regional Archives in Östergötland according to applicable laws and regulations.
The result of blood gas analysis is obtained from the digital lab system in the patient record (Lab-ROS) or directly exported from the internal memory of the analyzers at the emergency department. In both cases, the results will be used for digital compilation of study data. All electronic storage of study data will be pseudonymized by linking to patients serial number.
== Statistics ==
In previous studies, the correlation between arterial and venous samples has been evaluated using several different statistical methods:
- T-test, Pearson's and Spearman's R variable
- Descriptive data are presented as mean and +/- from SD
Our intention in this study is to make a parallel comparison of previously published methods, as well as to examine, based on collected data, whether a new formula with better precision can be derived.
== The potential significance of the project ==
At present, arterial blood gas sampling is used as the standard procedure for assessing a critically ill patient in the emergency department.
The project aims to clarify the feasibility of replacing routine arterial blood gas sampling in the emergency department with venous punctures without impairing test results and patient care. If feasible, such a change in sampling routines could potentially mean a great improvement for patients in terms of pain and complication risks. Also, workflow and lead times in the emergency department could be improved by the fact that venous samples may be drawn by all clinical staff, whereas arterial samples are normally reserved for doctors and nurses with dedicated training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indication for blood gas sampling | – | Diagnostic Test: Blood gas sampling from artery and veinTo be eligible, patients will need to be classified as critically ill and there has to be a clear clinical indication for an arterial blood gas sampling. Enrollment will be performed in a consecutive manner at all hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For enrolment, we will consider all patients who are admitted to the emergency department irrespective of mode of arrival (ambulance, walk-in etc). To be eligible, patients will need to be classified as critical ill and there has to be a clear clinical indication for an arterial blood gas sampling. Indications for arterial blood gas sampling, in turn, are primarily dictated by local SOPs (Standard Operating Procedures; "PM/ vårdprocessåtgärder") for appropriate sampling based on chief complaint, age, and vital signs upon arrival. The aim is to include these patients consecutively around-the-clock.
Key inclusion criteria (3 listed)
- Patients able to understand and process oral and written information and give his/her consent (within 12h), or consent provided by a close relative.
- Aged > 18 years
- Assessed to be in need of arterial blood gas analysis
Key exclusion criteria (4 listed)
- Unwilling to participate, or unable to understand the provided information
- Inability to give subsequently consent (> 12 hours) or unwillingness by close relative to provide consent.
- Pregnant
- Aged < 18 years
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 |
|---|---|---|
| Blood gas sampling from artery and veinPatients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples. | Diagnostic test | Indication for blood gas sampling |
Primary outcome
How does pCO2 correlate between arterial and venous blood gas samples?
Time frame: October - November 2020
Can a clinically reliable correlation be identified using a conversion model? (existing or new)
Time frame: October - November 2020
4 secondary outcomes
How does processing times and sampling location affect the result?
Time frame: October - November 2020
How does the patient's vital parameters (blood pressure, pulse) affect the results?
Time frame: October - November 2020
In there a difference in the analysis results between the emergency department and the central laboratory?
Time frame: October - November 2020
How reliable are the results beyond mild to moderate deviations from normal values in consecutive enrolled, critically ill patients?
Time frame: October - November 2020
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 16 Jun 2022.
- Background: PubMed 24009442Bengezi OA, Dalcin A, Al-Thani H, Bain JR. Unusual complication of radial artery cannulation. Can J Plast Surg. 2003 Winter;11(4):213-5. doi: 10.1177/229255030301100409.
- Background: PubMed 23903783Bloom BM, Grundlingh J, Bestwick JP, Harris T. The role of venous blood gas in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2014 Apr;21(2):81-8. doi: 10.1097/MEJ.0b013e32836437cf.
- BackgroundEMCrit, About, Josh Farkas, and The Emcrit Crew. 2017. "PulmCrit- How to Convert a VBG into an ABG." EMCrit Project. January 16, 2017. https://emcrit.org/pulmcrit/vbg-abg/.
- Background: PubMed 10769553Giner J, Casan P, Belda J, Litvan H, Sanchis J. [Use of the anesthetic cream EMLA in arterial punction]. Rev Esp Anestesiol Reanim. 2000 Feb;47(2):63-6. Spanish.
- Background: PubMed 1583545Hess D, Agarwal NN. Variability of blood gases, pulse oximeter saturation, and end-tidal carbon dioxide pressure in stable, mechanically ventilated trauma patients. J Clin Monit. 1992 Apr;8(2):111-5. doi: 10.1007/BF01617428.
- Background: PubMed 22581470Jang JS, Jin HY, Seo JS, Yang TH, Kim DK, Kim DK, Kim DI, Cho KI, Kim BH, Park YH, Je HG, Kim DS. The transradial versus the transfemoral approach for primary percutaneous coronary intervention in patients with acute myocardial infarction: a systematic review and meta-analysis. EuroIntervention. 2012 Aug;8(4):501-10. doi: 10.4244/EIJV8I4A78.
- Background: PubMed 11392573Kelly AM, McAlpine R, Kyle E. How accurate are pulse oximeters in patients with acute exacerbations of chronic obstructive airways disease? Respir Med. 2001 May;95(5):336-40. doi: 10.1053/rmed.2001.1046.
- Background: PubMed 25552544Kelly AM. Can VBG analysis replace ABG analysis in emergency care? Emerg Med J. 2016 Feb;33(2):152-4. doi: 10.1136/emermed-2014-204326. Epub 2014 Dec 31.
- Background: PubMed 22921853Lemoel F, Govciyan S, El Omri M, Marquette CH, Levraut J. Improving the validity of peripheral venous blood gas analysis as an estimate of arterial blood gas by correcting the venous values with SvO(2). J Emerg Med. 2013 Mar;44(3):709-16. doi: 10.1016/j.jemermed.2012.07.041. Epub 2012 Aug 24.
- Background: PubMed 17652681Malatesha G, Singh NK, Bharija A, Rehani B, Goel A. Comparison of arterial and venous pH, bicarbonate, PCO2 and PO2 in initial emergency department assessment. Emerg Med J. 2007 Aug;24(8):569-71. doi: 10.1136/emj.2007.046979.
- Background: PubMed 20134147O'Connor TM, Barry PJ, Jahangir A, Finn C, Buckley BM, El-Gammal A. Comparison of arterial and venous blood gases and the effects of analysis delay and air contamination on arterial samples in patients with chronic obstructive pulmonary disease and healthy controls. Respiration. 2011;81(1):18-25. doi: 10.1159/000281879. Epub 2010 Feb 4.
- Background: PubMed 12133178Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
- Complete study protocol as used for approval at the Swedish Ethical Review AuthorityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Jörg, MD principal investigator
Emergency Department, University Hospital Linköping, Sweden
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 Dyspnea and Hypercapnia, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 4 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 16 Jun 2022. 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 Sweden. 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?
How does pCO2 correlate between arterial and venous blood gas samples? (time frame: October - November 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409470, which also lists 16 linked publications.
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 16 Jun 2022.