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

October 16, 2018 updated by: Angelique Spoelstra-de Man, Amsterdam UMC, location VUmc

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

879

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1007 MB
        • VUMedicalCentre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prospective

  • ICU - VUmc: Critically ill patients, requiring invasive monitoring
  • Pulmonary function department - VUmc: Patients requiring a pulmonary function test with arterial bloodgas analysis.
  • ER VUmc: Patients presented at the shockroom or patients in the general ER, requiring arterial bloodgas analysis.

Retrospective

- Pulmonary function departments: Patients who underwent a pulmonary function test with arterial bloodgas analysis in the last 25 years.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation SpO2-PaO2
Time Frame: Average of one week
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
Time Frame: Average of one week
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
Time Frame: Average of one week
To determine differences in the SpO2/PaO2 -relationship in different populations
Average of one week
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
Average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Study Director: Angelique ME Spoelstra - de Man, Phd Md, Amsterdam Umc, Location Vumc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.524 (A2015.361)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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