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Completed

NCT Number: NCT02666937

Safe Limits in Saturation (SLIM-study)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VUMedicalCentre

Amsterdam, North Holland, 1007 MB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Relation SpO2-PaO2

    Time frame: Average of one week

    To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur

Secondary outcomes

  1. 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

  2. Relation in SpO2-PaO2 in different populations

    Time frame: Average of one week

    To determine differences in the SpO2/PaO2 -relationship in different populations

  3. 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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: SLIM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2016
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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