Safe Limits in Saturation (SLIM-study)

Overview

A study consisting of a prospective and retrospective cohort in the ICU, ER and pulmonary department in a university hospital in Amsterdam and a teaching hospital in Alkmaar, the Netherlands. The relationship between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is investigated in order to investigate which transcutaneous saturation values are safe when administering oxygen in relation to hyperopia and hypoxia.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: August 2017

Detailed Description

This study consists of two parts a prospective and a retrospective part. 1. Prospective part: Patients in the ICU, the emergency room and the pulmonary function department of the VU university medical centre will be included. Arterial blood gas analysis is a tool often used to determine PaO2 in regular care. When an arterial blood gas analysis is performed for regular patient care, the corresponding SpO2 is measured. Information such as blood pressure, heart rate, amount of administered fluids and shock-related-parameters are obtained from the patient files. For the ICU patients capillary refill, acra temperature and the mottling scores are examined. The peripheral flow index and temperature index is measured. When more arterial blood gas samples are drawn over time in one patient, multiple datasets can be included per patient, as long as the samples are drawn two hours apart. 2. Retrospective part: Patients with a (suspected) pulmonary disease who underwent pulmonary function tests with arterial bloodgas sampling in the VU medical center and Medical Centre Alkmaar in the last 25 years. The PaO2 and corresponding SpO2 will be obtained from the test and parameters such as blood pressure, heart rate and administered oxygen will be retrieved from the databases with these test results.

Arms, Groups and Cohorts

  • ICU-patients (prospective)
    • Critically ill patients (18 years and older) on mechanically ventilation who have an arterial line and require bloodgasanalysis for medical reasons
  • Emergency Department (prospective)
    • Patients (18 years and older), who are presented to the Emergency Department, and require bloodgasanalysis for medical reasons
  • Pulmonary department (prospective)
    • Patients (18 years and older) who visit the outpatient clinic of the pulmonary department for different pulmonary functional test and require bloodgasanalysis for medical reasons
  • Pulmonary department (retrospective)
    • Patients (18 years and older) who visited the outpatient clinic of the pulmonary department in the past of the VU medical centre in Amsterdam or the Medical Centre Alkmaar for different pulmonary functional test and required bloodgasanalysis for medical reasons

Clinical Trial Outcome Measures

Primary Measures

  • Relation SpO2-PaO2
    • Time Frame: Average of one week
    • To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur

Secondary Measures

  • Factors influencing PaO2-Spo2 relation
    • Time Frame: Average of one week
    • To identify factors influencing the relationship between SpO2 and PaO2, such as hemodynamics, peripheral circulation, shock and pH
  • Relation in SpO2-PaO2 in different populations
    • Time Frame: Average of one week
    • To determine differences in the SpO2/PaO2 -relationship in different populations
  • Differences in relation in SpO2-PaO2 prospective versus retrospective
    • Time Frame: Average of one week
    • To determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort

Participating in This Clinical Trial

Inclusion criteria for all inclusions:

  • Age: 18> – Requiring arterial bloodgas analysis Exclusion criteria for all inclusions: – Hyperbilirubinemia (>20 μmol/L) – CO-Hb (>1,5%) – MetHb (>1,5%) – Unreliable pulsatile SpO2 curve Additional inclusion criteria:

  • Prospective, ICU – VUmc: On mechanical ventilation. Arterial line in place. Additional exclusion criteria:

  • Prospective, ICU – VUmc: On extracorporeal membrane oxygenation. Therapeutic hypothermia. – Retrospective, Pulmonary function departments: Uncertainty whether SpO2 was measured exactly during arterial bloodgas sampling.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amsterdam UMC, location VUmc
  • Provider of Information About this Clinical Study
    • Principal Investigator: Angelique Spoelstra-de Man, Dr. A.M.E. Spoelstra–de Man – Amsterdam UMC, location VUmc
  • Overall Official(s)
    • Angelique ME Spoelstra – de Man, Phd Md, Study Director, Amsterdam UMC, location VUmc

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