Safe Limits in Saturation (SLIM-study)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This study consists of two parts a prospective and a retrospective part. 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. 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.

Official Title
-----------------
Safe Limits in Saturation (SLIM-study)

Conditions
-----------------
Critical Illness, Hyperoxia, Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU-patients (prospective)<br>Critically ill patients (18 years and older) on mechanically ventilation who have an arterial line and require bloodgasanalysis for medical reasons | |
| Emergency Department (prospective)<br>Patients (18 years and older), who are presented to the Emergency Department, and require bloodgasanalysis for medical reasons | |
| Pulmonary department (prospective)<br>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)<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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