Critical IllnessSLIMNCT02666937
Safe Limits in Saturation (SLIM-study)
An observational study of Critical Illness and Hyperoxia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Hyperoxia, Hypoxia
- How many people
- 879 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: 18>
- Requiring arterial bloodgas analysis
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the detailed 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.
- Conditions
- Critical Illness, Hyperoxia, Hypoxia
- Medical subject headings
- Critical Illness, Hyperoxia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Relation SpO2-PaO2
To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur
Measured: Average of one week
Secondary outcomes (3)
Factors influencing PaO2-Spo2 relation
To identify factors influencing the relationship between SpO2 and PaO2, such as hemodynamics, peripheral circulation, shock and pH
Measured: Average of one week
Relation in SpO2-PaO2 in different populations
To determine differences in the SpO2/PaO2 -relationship in different populations
Measured: Average of one week
Differences in relation in SpO2-PaO2 prospective versus retrospective
To determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort
Measured: Average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelique Spoelstra-de Man, Amsterdam UMC, location VUmc
- Investigators
- Angelique ME Spoelstra - de Man, Phd Md, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666937
- Sponsor's protocol ID
- 2014.524 (A2015.361)
- Acronym
- SLIM
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2015
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cornet AD, Kooter AJ, Peters MJ, Smulders YM. Supplemental oxygen therapy in medical emergencies: more harm than benefit? Arch Intern Med. 2012 Feb 13;172(3):289-90. doi: 10.1001/archinternmed.2011.624. Epub 2012 Jan 9. No abstract available.
PubMed 22231614de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10.
PubMed 19077208Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ. 2010 Oct 18;341:c5462. doi: 10.1136/bmj.c5462.
PubMed 20959284Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707.
PubMed 20516417Kuisma M, Boyd J, Voipio V, Alaspaa A, Roine RO, Rosenberg P. Comparison of 30 and the 100% inspired oxygen concentrations during early post-resuscitation period: a randomised controlled pilot study. Resuscitation. 2006 May;69(2):199-206. doi: 10.1016/j.resuscitation.2005.08.010. Epub 2006 Feb 24.
PubMed 16500018Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8.
PubMed 21385416Meyhoff CS, Jorgensen LN, Wetterslev J, Christensen KB, Rasmussen LS; PROXI Trial Group. Increased long-term mortality after a high perioperative inspiratory oxygen fraction during abdominal surgery: follow-up of a randomized clinical trial. Anesth Analg. 2012 Oct;115(4):849-54. doi: 10.1213/ANE.0b013e3182652a51. Epub 2012 Jul 13.
PubMed 22798533Quintard H, Patet C, Suys T, Marques-Vidal P, Oddo M. Normobaric hyperoxia is associated with increased cerebral excitotoxicity after severe traumatic brain injury. Neurocrit Care. 2015 Apr;22(2):243-50. doi: 10.1007/s12028-014-0062-0.
PubMed 25168744Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
PubMed 24164953Baleeiro CE, Wilcoxen SE, Morris SB, Standiford TJ, Paine R 3rd. Sublethal hyperoxia impairs pulmonary innate immunity. J Immunol. 2003 Jul 15;171(2):955-63. doi: 10.4049/jimmunol.171.2.955.
PubMed 12847267Davis WB, Rennard SI, Bitterman PB, Crystal RG. Pulmonary oxygen toxicity. Early reversible changes in human alveolar structures induced by hyperoxia. N Engl J Med. 1983 Oct 13;309(15):878-83. doi: 10.1056/NEJM198310133091502.
PubMed 6888481Jackson RM. Pulmonary oxygen toxicity. Chest. 1985 Dec;88(6):900-5. doi: 10.1378/chest.88.6.900.
PubMed 3905287Fracica PJ, Knapp MJ, Piantadosi CA, Takeda K, Fulkerson WJ, Coleman RE, Wolfe WG, Crapo JD. Responses of baboons to prolonged hyperoxia: physiology and qualitative pathology. J Appl Physiol (1985). 1991 Dec;71(6):2352-62. doi: 10.1152/jappl.1991.71.6.2352.
PubMed 1778933Harten JM, Anderson KJ, Angerson WJ, Booth MG, Kinsella J. The effect of normobaric hyperoxia on cardiac index in healthy awake volunteers. Anaesthesia. 2003 Sep;58(9):885-8. doi: 10.1046/j.1365-2044.2003.03333.x.
PubMed 12911363Lodato RF. Decreased O2 consumption and cardiac output during normobaric hyperoxia in conscious dogs. J Appl Physiol (1985). 1989 Oct;67(4):1551-9. doi: 10.1152/jappl.1989.67.4.1551.
PubMed 2793757
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Limits in Saturation (SLIM-study)
- ClinicalTrials.gov ID
- NCT02666937
- Acronym / sponsor ID
- SLIM / 2014.524 (A2015.361)
- Conditions
- Critical Illness, Hyperoxia, Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age: 18>
- Requiring arterial bloodgas analysis
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relation SpO2-PaO2
Time frame: Average of one week
To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur
3 secondary outcomes
Factors influencing PaO2-Spo2 relation
Time frame: Average of one week
Relation in SpO2-PaO2 in different populations
Time frame: Average of one week
Differences in relation in SpO2-PaO2 prospective versus retrospective
Time frame: Average of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Background: PubMed 22231614Cornet AD, Kooter AJ, Peters MJ, Smulders YM. Supplemental oxygen therapy in medical emergencies: more harm than benefit? Arch Intern Med. 2012 Feb 13;172(3):289-90. doi: 10.1001/archinternmed.2011.624. Epub 2012 Jan 9. No abstract available.
- Background: PubMed 19077208de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10.
- Background: PubMed 20959284Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ. 2010 Oct 18;341:c5462. doi: 10.1136/bmj.c5462.
- Background: PubMed 20516417Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707.
- Background: PubMed 16500018Kuisma M, Boyd J, Voipio V, Alaspaa A, Roine RO, Rosenberg P. Comparison of 30 and the 100% inspired oxygen concentrations during early post-resuscitation period: a randomised controlled pilot study. Resuscitation. 2006 May;69(2):199-206. doi: 10.1016/j.resuscitation.2005.08.010. Epub 2006 Feb 24.
- Background: PubMed 21385416Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8.
- Background: PubMed 22798533Meyhoff CS, Jorgensen LN, Wetterslev J, Christensen KB, Rasmussen LS; PROXI Trial Group. Increased long-term mortality after a high perioperative inspiratory oxygen fraction during abdominal surgery: follow-up of a randomized clinical trial. Anesth Analg. 2012 Oct;115(4):849-54. doi: 10.1213/ANE.0b013e3182652a51. Epub 2012 Jul 13.
- Background: PubMed 25168744Quintard H, Patet C, Suys T, Marques-Vidal P, Oddo M. Normobaric hyperoxia is associated with increased cerebral excitotoxicity after severe traumatic brain injury. Neurocrit Care. 2015 Apr;22(2):243-50. doi: 10.1007/s12028-014-0062-0.
- Background: PubMed 24164953Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
- Background: PubMed 12847267Baleeiro CE, Wilcoxen SE, Morris SB, Standiford TJ, Paine R 3rd. Sublethal hyperoxia impairs pulmonary innate immunity. J Immunol. 2003 Jul 15;171(2):955-63. doi: 10.4049/jimmunol.171.2.955.
- Background: PubMed 6888481Davis WB, Rennard SI, Bitterman PB, Crystal RG. Pulmonary oxygen toxicity. Early reversible changes in human alveolar structures induced by hyperoxia. N Engl J Med. 1983 Oct 13;309(15):878-83. doi: 10.1056/NEJM198310133091502.
- Background: PubMed 3905287Jackson RM. Pulmonary oxygen toxicity. Chest. 1985 Dec;88(6):900-5. doi: 10.1378/chest.88.6.900.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique ME Spoelstra - de Man, Phd Md study director
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Hyperoxia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation SpO2-PaO2 (time frame: Average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666937, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018; AzTrials last refreshed its copy on 2 Nov 2026.