Arterial Pulsed Oxygen SaturationPULSEREANCT02832817
Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation
An observational study of Arterial Pulsed Oxygen Saturation, run by University Hospital, Angers at 1 site in France.
Trial summary
Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units or perioperative. The mortality and morbidity increase for cardiovascular reason, due to hypoxia has been reported several times. It is therefore important to detect hypoxemia very early and with accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Pulsed Oxygen Saturation
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2016to Dec 2017
- 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: General population of Intensive Care Unit
Who may be able to join
- Hospitalization in intensive care
- Over 18 years
- Continuous monitoring of oxygen saturation
- Susceptible oo have arterial blood gases and carrying an arterial catheter
Who cannot join
- patient protected by the law
- no social security number
- carbon monoxide Intoxication
- High methemoglobinemia.
- Therapeutic limitation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Réanimation Chirurgicale
Angers, 49933
Thomas REYDEL, Dr, Thomas.Reydel@chu-angers.fr
About this study
Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units or perioperative. The mortality and morbidity increase for cardiovascular reason, due to hypoxia has been reported several times. It is therefore important to detect hypoxemia very early and with accuracy. The objective is to correct the causes quickly and thus avoid or minimize complications.
In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to the formation of free radicals, which in physiological condition are regulated by antioxidant mechanisms. However, in anesthesiology, it is common to find pathological situations (acute respiratory distress syndrome, shock, prolonged inflammatory state) where these regulatory mechanisms are overwhelmed. Oxygen administration to supra-physiological concentrations leads to a formation of excessive free radicals, aggravating the existing injury (including lung).
Read more
Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and tolerance. Currently, the standard method for assessing oxygenation is the arterial blood gas analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial blood sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen Saturation, called "pulse oximeters." Pulse oximeters have become an integral and mandatory part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So pulse oximetry is a method considered reliable and especially non-invasive. It is less expensive and does not require blood sampling. These qualities explain why these devices are easily used in anesthesia, intensive care and in emergency situations.
However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is necessary to objectify the benefits and limitations of pulse oximetry to optimize their use, especially in these situations of high risk, where a discrepancy between the values measured by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be detrimental.
It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a comparative study.
- Conditions
- Arterial Pulsed Oxygen Saturation
- Being tested
- Pulse oximeter
- Keywords
- Oxygen therapy, Pulse oximeter, Hypoxia, Hypoxemia, Arterial blood gas
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
For each monitoring of Arterial Oxygen Saturation, measures of Arterial Pulsed Oxygen Saturation will be made for each pulse oximeter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation by pulse oximetry monitoring accuracy
determine the accuracy of oxygen saturation by pulse oximetry monitoring devices (SpO2) compared to the reference method, arterial oxygen saturation (SaO2) by blood gas on Co-Oximeter
Measured: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)
Secondary outcomes (1)
Number of participants for whom there will be mismatch between SpO2 (oxygen saturation by pulse oximetry) and SaO2 (arterial oxygen saturation) measures with medical adverse events (vasopressors, hypoxemia, acidosis, alkalosis)
highlight groups with risks of discrepancy between SpO2 and Sa02, and describe with the following criteria : presence of vasopressors, mechanical ventilation, blood lactate value, hypoxemia, acidosis / alkalosis, skin hypoperfusion signs, skin phototype, temperature.
Measured: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start20 Feb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Pulsed Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832817
- Sponsor's protocol ID
- PULSEREA2016
- Acronym
- PULSEREA
- Status last verified
- May 2017
- First submitted
- 20 Jun 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation
- ClinicalTrials.gov ID
- NCT02832817
- Acronym / sponsor ID
- PULSEREA / PULSEREA2016
- Conditions
- Arterial Pulsed Oxygen Saturation
- Keywords
- Oxygen therapy, Pulse oximeter, Hypoxia, Hypoxemia, Arterial blood gas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Feb 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 2016 (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.
Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units or perioperative. The mortality and morbidity increase for cardiovascular reason, due to hypoxia has been reported several times. It is therefore important to detect hypoxemia very early and with accuracy. The objective is to correct the causes quickly and thus avoid or minimize complications.
In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to the formation of free radicals, which in physiological condition are regulated by antioxidant mechanisms. However, in anesthesiology, it is common to find pathological situations (acute respiratory distress syndrome, shock, prolonged inflammatory state) where these regulatory mechanisms are overwhelmed. Oxygen administration to supra-physiological concentrations leads to a formation of excessive free radicals, aggravating the existing injury (including lung).
Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and tolerance. Currently, the standard method for assessing oxygenation is the arterial blood gas analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial blood sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen Saturation, called "pulse oximeters." Pulse oximeters have become an integral and mandatory part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So pulse oximetry is a method considered reliable and especially non-invasive. It is less expensive and does not require blood sampling. These qualities explain why these devices are easily used in anesthesia, intensive care and in emergency situations.
However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is necessary to objectify the benefits and limitations of pulse oximetry to optimize their use, especially in these situations of high risk, where a discrepancy between the values measured by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be detrimental.
It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a comparative study.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population of Intensive Care Unit
Key inclusion criteria (4 listed)
- Hospitalization in intensive care
- Over 18 years
- Continuous monitoring of oxygen saturation
- Susceptible oo have arterial blood gases and carrying an arterial catheter
Key exclusion criteria (5 listed)
- patient protected by the law
- no social security number
- carbon monoxide Intoxication
- High methemoglobinemia.
- Therapeutic limitation
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 |
|---|---|---|
| Pulse oximeterFor each monitoring of Arterial Oxygen Saturation, measures of Arterial Pulsed Oxygen Saturation will be made for each pulse oximeter. | Device | – |
Primary outcome
Oxygen saturation by pulse oximetry monitoring accuracy
Time frame: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)
determine the accuracy of oxygen saturation by pulse oximetry monitoring devices (SpO2) compared to the reference method, arterial oxygen saturation (SaO2) by blood gas on Co-Oximeter
1 secondary outcome
Number of participants for whom there will be mismatch between SpO2 (oxygen saturation by pulse oximetry) and SaO2 (arterial oxygen saturation) measures with medical adverse events (vasopressors, hypoxemia, acidosis, alkalosis)
Time frame: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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.
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 Arterial Pulsed Oxygen Saturation, run by University Hospital, Angers at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 11 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas REYDEL, Dr (02413555225 ext. 0033, Thomas.Reydel@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation by pulse oximetry monitoring accuracy (time frame: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)). 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 May 2017.