Safe Limits in Saturation (SLIM-study)

Critical Illness Clinical Trial

— SLIM  

Official title:

Safe Limits in Saturation (SLIM-study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666937
• Other study ID #: 2014.524 (A2015.361)
• Status: Completed
• Start date: December 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2018
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 879
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Hyperoxia
• Hypoxia

Locations

Country	Name	City	State
Netherlands	VUMedicalCentre	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation SpO2-PaO2	To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur	Average of one week
Secondary	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
Secondary	Relation in SpO2-PaO2 in different populations	To determine differences in the SpO2/PaO2 -relationship in different populations	Average of one week
Secondary	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

External Links

•   Principles of oximetry