Oxygen Saturation: Analytical Comparison for COVID (SHOCOVID)
Primary Purpose
Hypoxemia, Covid-19
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of oxygen saturation
Sponsored by
About this trial
This is an interventional other trial for Hypoxemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR-R3S) Hôpital Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Major patient admitted to the ICU for COVID
Arm Description
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04874805
First Posted
April 16, 2021
Last Updated
May 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04874805
Brief Title
Oxygen Saturation: Analytical Comparison for COVID
Acronym
SHOCOVID
Official Title
Oxygen Hemoglobin Saturation in COVID Patients: Comparison of Arterial Gasometry and Pulse Oximetry
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
since the departure of Dr. LEFRERE no investigator has decided to take over the project
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Covid-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Major patient admitted to the ICU for COVID
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Measurement of oxygen saturation
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the accuracy of SpO2 value provided by portable pulse oximeter in COVID patients compared with the reference method.
Description
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%.
Time Frame
once a day
Secondary Outcome Measure Information:
Title
Identification of pathophysiological or analytical biases specific to COVID patients.
Description
Data analysis will allow to identify potential biases in the measurement of oxygen saturation in COVID patients
Time Frame
through study completion, an average of 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR-R3S) Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Oxygen Saturation: Analytical Comparison for COVID
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