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

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ClinicalTrials.gov Identifier: NCT02832817
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Arterial Pulsed Oxygen Saturation Device: Pulse oximeter

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation
Actual Study Start Date : February 20, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Pulse oximeter
    For each monitoring of Arterial Oxygen Saturation, measures of Arterial Pulsed Oxygen Saturation will be made for each pulse oximeter.

Outcome Measures

Primary Outcome Measures :
  1. Oxygen saturation by pulse oximetry monitoring accuracy [ Time Frame: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week) ]
    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


Secondary Outcome Measures :
  1. 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) [ Time Frame: at each arterial blood gas during ICU hospitalization (max 5 punctures from inclusion to ICU discharge - average of 1 week) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population of Intensive Care Unit
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832817


Contacts
Contact: Thomas REYDEL, Dr 02413555225 ext 0033 Thomas.Reydel@chu-angers.fr
Contact: Laurent BEYDON, Pr 02413553951 ext 0033 labeydon@chu-angers.fr

Locations
France
Service de Réanimation Chirurgicale Recruiting
Angers, France, 49933
Contact: Thomas REYDEL, Dr       Thomas.Reydel@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02832817     History of Changes
Other Study ID Numbers: PULSEREA2016
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Angers:
Oxygen therapy
Pulse oximeter
Hypoxia
Hypoxemia
Arterial blood gas