An observational study in Hyperoxia and Cardiac Output, Low, sponsored by Frisius Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-26.
Sponsored by Frisius Medisch Centrum · Observational
Rational: Preoxygenation is a standard procedure before (deep) sedation in the ED. However, there is literature suggesting that too much oxygen can be harmful. One potential detrimental effect is a decrease in cardiac output due to coronary vasoconstriction. So far, it is unknown if this effect is rate dependent and if it also occurs after only a short period of hyperoxia, as patients experience during procedural sedation pre-oxygenation.
Objective: To investigate if hyperoxia has a negative effect on Cardiac index (CI) in patients undergoing procedural sedation in the ED.
Methods: In patients needing sedation for a painful condition, non-invasive measurements of CI, stroke volume and total peripheral resistance are performed using the Clearsight non-invasive cardiac output monitoring system.. Measurements will be taken at baseline, after 1,2 and 5 minutes of 15L O2/min, and then after another 2 and 5 minutes of flush rate oxygen and during the subsequent sedation.
124 studies on the registry are indexed under Hyperoxia; 19 are open to participants now.
This study's enrollment of 60 is below the median of 110 across 25 observational studies indexed under Hyperoxia.
Browse Hyperoxia studies →Frisius Medisch Centrum is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
- Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements
The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline
Cardiac output is measured by Clearsight non invasive hemodynamic monitoring system; 3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
Time frame: at baseline, at 1,2,5 (15L),7 and 10 minutes (flush o2)
The change in heart rate (BPM) after respectively 15L/min and flush rate preoxygenation in respect to baseline
3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
Time frame: at baseline, at 1,2,5, (15L o2) and 7, 10 minutes (flush o2)
the change in systolic blood pressure (mmHg) after respectively 15L/min and flush rate preoxygenation in respect to baseline
Systolic blood pressure is measured by Clearsight non invasive hemodynamic monitoring system; 3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
Time frame: at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)
The change in stroke volume (ml) after respectively 15L/min and flush rate preoxygenation in respect to baseline
Stroke volume is measured by Clearsight non invasive hemodynamic monitoring system; 3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
Time frame: at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)
the change in total peripheral vascular resistance after respectively 15L/min and flush rate preoxygenation in respect to baseline
Peripheral vascular resistance is measured by Clearsight non invasive hemodynamic monitoring system; 3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
Time frame: at baseline, at 1,2,5 (15L o2) and 7,10 minutes (flush o2)
The relation of the difference in CI with the occurrence of of haemodynamic sedation events
In case of apnea \> 20 sec, low SBP \<90 mmHg or \>20% decrease in comparison to baseline, desaturation \<92%, assess relation to change in cardiac output (L/min) during preoxygenation
Time frame: at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2)
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jun 2019, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Frisius Medisch Centrum