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Safe Limits in Saturation (SLIM-study)

A

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Hyperoxia
Critical Illness
Hypoxia

Study type

Observational

Funder types

Other

Identifiers

NCT02666937
2014.524 (A2015.361)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

879 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

879 participants in 4 patient groups

ICU-patients (prospective)
Description:
Critically ill patients (18 years and older) on mechanically ventilation who have an arterial line and require bloodgasanalysis for medical reasons
Emergency Department (prospective)
Description:
Patients (18 years and older), who are presented to the Emergency Department, and require bloodgasanalysis for medical reasons
Pulmonary department (prospective)
Description:
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)
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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