Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation (PULSEREA)

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 Overview

• Status: Unknown
• Conditions: Arterial Pulsed Oxygen Saturation
• Intervention / Treatment: Device: Pulse oximeter

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Thomas REYDEL, Dr; Phone Number: 0033 02413555225; Email: Thomas.Reydel@chu-angers.fr
• Study Contact Backup: Name: Laurent BEYDON, Pr; Phone Number: 0033 02413553951; Email: labeydon@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • Service de Réanimation Chirurgicale
    • Contact: Thomas REYDEL, Dr; Email: Thomas.Reydel@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General population of Intensive Care Unit

Description

Inclusion Criteria:

• Hospitalization in intensive care
• Over 18 years
• Continuous monitoring of oxygen saturation
• Susceptible oo have arterial blood gases and carrying an arterial catheter

Exclusion Criteria:

• patient protected by the law
• no social security number
• carbon monoxide Intoxication
• High methemoglobinemia.
• Therapeutic limitation

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week)

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hypoxia; Oxygen therapy; Arterial blood gas; Pulse oximeter; Hypoxemia
• Other Study ID Numbers: PULSEREA2016