HypoxemiaSHOCOVIDNCT04874805
Oxygen Saturation: Analytical Comparison for COVID
A study testing Measurement of oxygen saturation in people with Hypoxemia and Covid-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In many patients, respiratory Sars-Cov2 infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Measurement of oxygen saturation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2022to 2 May 2022
- Phase
- Interventional
- 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
- Patients hospitalized in the intensive care unit for COVID
- Age ≥ 18 years
- Patients or family/trusted person informed and not objecting to participating in the research
Who cannot join
- Carbon monoxide poisoning
- Homozygous sickle cell disease
- Severe anemia (< 7 g/L) with associated hypoxemia
- Methemoglobinemia
- Sulfhemoglobinemia
- Sepsis, vasoconstrictive drugs
- Patients under guardianship / curators
- Patient under state medical aid
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR-R3S) Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Oxygen Hemoglobin Saturation in COVID Patients: Comparison of Arterial Gasometry and Pulse Oximetry
In many patients, respiratory Sars-Cov2 infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Hypoxemia has been shown to be predictively associated with admission to the ICU. Therefore, the question of constant monitoring of oxygenation, practiced on a large scale, at home, in asymptomatic patients or contact cases, arises. A large number of portable pulse oximeter are currently freely available on the market; however, their clinical validation remains sometimes doubtful, or even absent from FDA standards.
The objective of this study is to evaluate the accuracy of SpO2 values provided by portable pulse oximeter in COVID patients, in comparison with the reference method. The study will be conducted on a population of adult patients with COVID, hospitalized in the ICU, for whom gasometry sampling is already scheduled in the usual management.
Read the detailed description
The constant monitoring of saturation by the pulse oximeter, the result of three centuries of technological progress, has introduced a true revolution in medical management that now relies on this vital parameter. In many patients, Sars-Cov2 respiratory infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a certain point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Hypoxemia has been shown to be predictively associated with admission to the ICU. Therefore, the question of constant monitoring of oxygenation, practiced on a large scale, at home, in asymptomatic patients or contact cases, arises.
Despite its many advantages (non-invasive, kinetic), the pulse oximeter can be misused in several pathophysiological situations. The reference method for measuring hemoglobin oxygen saturation remains arterial gasometry.
However, a large number of portable pulse oximeter are currently freely available on the market; however, their clinical validation is sometimes questionable or even absent from FDA standards.
The objective of this study is to evaluate the accuracy of SpO2 values provided by portable pulse oximeter in COVID patients, in comparison with the reference method (arterial gasometry). The study will be conducted on a population of adult patients with COVID, hospitalized in the ICU, for whom gasometry sampling is already scheduled in the usual management.
Daily at 6am, during the systematic monitoring, arterial gasometry will be taken (as part of routine care) by the nurse or medical staff on duty. Synchronous measurement of Sp02 given by three portable pulse oximeter (1 measurement point per device, therefore 3 measurements/patient/day for a minimum of 3 days).
- Being tested
- Measurement of oxygen saturation
- Medical subject headings
- Hypoxia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of oxygen saturationOther
Measurement of oxygen saturation by pulse oximetry once a day, at 6 a.m., for a minimum of 3 days, thanks to three pulse oximeters (1 measurement point per device/day), in parallel with a synchronous sampling, programmed as part of the usual care, of arterial gasometry.
| Study group | Role | What they receive |
|---|---|---|
| Major patient admitted to the ICU for COVID | Experimental | Not described Receives: Other: Measurement of oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy of SpO2 value provided by portable pulse oximeter in COVID patients compared with the reference method.
Measurement of oxygen saturation by pulse oximetry once a day, at 6 a.m., for a minimum of 3 days, using three pulse oximeters (1 measurement point per device/day), in parallel with a synchronous, programmed arterial gasometry sampling Evaluation according to the standards of the SFBC (French Society of Clinical Biology) for the comparison of methods: minimum 40 points per apparatus, evenly distributed over the pathophysiological range of the saturations explored (9, 10): 60-100%.
Measured: once a day
Secondary outcomes (1)
Identification of pathophysiological or analytical biases specific to COVID patients.
Data analysis will allow to identify potential biases in the measurement of oxygen saturation in COVID patients
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start2 May 2022
- Primary completion2 May 2022
- Study completion2 May 2022
Why it stopped: since the departure of Dr. LEFRERE no investigator has decided to take over the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874805
- Sponsor's protocol ID
- APHP210142
- Acronym
- SHOCOVID
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Hemoglobin Saturation in COVID Patients: Comparison of Arterial Gasometry and Pulse Oximetry
- ClinicalTrials.gov ID
- NCT04874805
- Acronym / sponsor ID
- SHOCOVID / APHP210142
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: since the departure of Dr. LEFRERE no investigator has decided to take over the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 6 May 2021 (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 many patients, respiratory Sars-Cov2 infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Hypoxemia has been shown to be predictively associated with admission to the ICU. Therefore, the question of constant monitoring of oxygenation, practiced on a large scale, at home, in asymptomatic patients or contact cases, arises. A large number of portable pulse oximeter are currently freely available on the market; however, their clinical validation remains sometimes doubtful, or even absent from FDA standards.
The objective of this study is to evaluate the accuracy of SpO2 values provided by portable pulse oximeter in COVID patients, in comparison with the reference method. The study will be conducted on a population of adult patients with COVID, hospitalized in the ICU, for whom gasometry sampling is already scheduled in the usual management.
Detailed description
The constant monitoring of saturation by the pulse oximeter, the result of three centuries of technological progress, has introduced a true revolution in medical management that now relies on this vital parameter. In many patients, Sars-Cov2 respiratory infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a certain point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Hypoxemia has been shown to be predictively associated with admission to the ICU. Therefore, the question of constant monitoring of oxygenation, practiced on a large scale, at home, in asymptomatic patients or contact cases, arises.
Despite its many advantages (non-invasive, kinetic), the pulse oximeter can be misused in several pathophysiological situations. The reference method for measuring hemoglobin oxygen saturation remains arterial gasometry.
However, a large number of portable pulse oximeter are currently freely available on the market; however, their clinical validation is sometimes questionable or even absent from FDA standards.
The objective of this study is to evaluate the accuracy of SpO2 values provided by portable pulse oximeter in COVID patients, in comparison with the reference method (arterial gasometry). The study will be conducted on a population of adult patients with COVID, hospitalized in the ICU, for whom gasometry sampling is already scheduled in the usual management.
Daily at 6am, during the systematic monitoring, arterial gasometry will be taken (as part of routine care) by the nurse or medical staff on duty. Synchronous measurement of Sp02 given by three portable pulse oximeter (1 measurement point per device, therefore 3 measurements/patient/day for a minimum of 3 days).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major patient admitted to the ICU for COVID | Experimental | Other: Measurement of oxygen saturation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized in the intensive care unit for COVID
- Age ≥ 18 years
- Patients or family/trusted person informed and not objecting to participating in the research
Key exclusion criteria (8 listed)
- Carbon monoxide poisoning
- Homozygous sickle cell disease
- Severe anemia (< 7 g/L) with associated hypoxemia
- Methemoglobinemia
- Sulfhemoglobinemia
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 |
|---|---|---|
| Measurement of oxygen saturationMeasurement of oxygen saturation by pulse oximetry once a day, at 6 a.m., for a minimum of 3 days, thanks to three pulse oximeters (1 measurement point per device/day), in parallel with a synchronous sampling, programmed as part of the usual care, of arterial gasometry. | Other | Major patient admitted to the ICU for COVID |
Primary outcome
To evaluate the accuracy of SpO2 value provided by portable pulse oximeter in COVID patients compared with the reference method.
Time frame: once a day
Measurement of oxygen saturation by pulse oximetry once a day, at 6 a.m., for a minimum of 3 days, using three pulse oximeters (1 measurement point per device/day), in parallel with a synchronous, programmed arterial gasometry sampling Evaluation according to the standards of the SFBC (French Society of Clinical Biology) for the comparison of methods: minimum 40 points per apparatus, evenly distributed over the pathophysiological range of the saturations explored (9, 10): 60-100%.
1 secondary outcome
Identification of pathophysiological or analytical biases specific to COVID patients.
Time frame: through study completion, an average of 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of oxygen saturation in people with Hypoxemia and Covid-19, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 May 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 evaluate the accuracy of SpO2 value provided by portable pulse oximeter in COVID patients compared with the reference method. (time frame: once a day). 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 10 May 2022.