Oxygen Saturation: Analytical Comparison for COVID

NCT04874805 | Withdrawn

• 1 other identifier: APHP210142
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; Covid-19

Outcome Measures

Primary Outcomes (1)

• 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%.

  once a day

Secondary Outcomes (1)

• Identification of pathophysiological or analytical biases specific to COVID patients.

  through study completion, an average of 7 months

Study Arms (1)

Major patient admitted to the ICU for COVID

EXPERIMENTAL

Other: Measurement of oxygen saturation

Interventions

Measurement of oxygen saturation 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.

Major patient admitted to the ICU for COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75013, France

Location

MeSH Terms

Conditions

Hypoxia; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 6, 2021
• Study Start: May 2, 2022
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

FR (1)