Oxygen Saturation: Analytical Comparison for COVID

NCT ID: NCT04874805

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2022-05-02

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).

Conditions

Hypoxemia; Covid-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Major patient admitted to the ICU for COVID

Group Type: EXPERIMENTAL

Measurement of oxygen saturation

Intervention Type: OTHER

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.

Interventions

Measurement of oxygen saturation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR-R3S) Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

APHP210142

Identifier Type: -

Identifier Source: org_study_id