Safe Limits in Saturation (SLIM-study)

NCT02666937 | Completed

• 1 other identifier: 2014.524 (A2015.361)
• Study Type: observational
• Target: 879
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Hyperoxia; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Relation SpO2-PaO2

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

  Average of one week

Secondary Outcomes (3)

• Factors influencing PaO2-Spo2 relation

  Average of one week

• Relation in SpO2-PaO2 in different populations

  Average of one week

• Differences in relation in SpO2-PaO2 prospective versus retrospective

  Average of one week

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age: 18\>
• Requiring arterial bloodgas analysis

You may not qualify if:

• Hyperbilirubinemia (\>20 μmol/L)
• CO-Hb (\>1,5%)
• MetHb (\>1,5%)
• Unreliable pulsatile SpO2 curve
• \- Prospective, ICU - VUmc: On mechanical ventilation. Arterial line in place.
• Prospective, ICU - VUmc: On extracorporeal membrane oxygenation. Therapeutic hypothermia.
• Retrospective, Pulmonary function departments: Uncertainty whether SpO2 was measured exactly during arterial bloodgas sampling.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VUMedicalCentre

Amsterdam, North Holland, 1007 MB, Netherlands

Location

Related Publications (29)

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• Durlinger EMJ, Spoelstra-de Man AME, Smit B, de Grooth HJ, Girbes ARJ, Oudemans-van Straaten HM, Smulders YM. Hyperoxia: At what level of SpO2 is a patient safe? A study in mechanically ventilated ICU patients. J Crit Care. 2017 Jun;39:199-204. doi: 10.1016/j.jcrc.2017.02.031. Epub 2017 Mar 2.

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MeSH Terms

Conditions

Critical Illness; Hyperoxia; Hypoxia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Angelique ME Spoelstra - de Man, Phd Md

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A.M.E. Spoelstra--de Man

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: January 28, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

NL (1)