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Safe Limits in Saturation (SLIM-study)

Safe Limits in Saturation (SLIM-study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02666937
Acronym
SLIM
Enrollment
879
Registered
2016-01-28
Start date
2015-12-31
Completion date
2017-08-31
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hyperoxia, Hypoxia

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. 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.

Interventions

None listed

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relation SpO2-PaO2Average of one weekTo determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur

Secondary

MeasureTime frameDescription
Factors influencing PaO2-Spo2 relationAverage of one weekTo identify factors influencing the relationship between SpO2 and PaO2, such as hemodynamics, peripheral circulation, shock and pH
Relation in SpO2-PaO2 in different populationsAverage of one weekTo determine differences in the SpO2/PaO2 -relationship in different populations
Differences in relation in SpO2-PaO2 prospective versus retrospectiveAverage of one weekTo determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026