The Effect of Hyperoxia on Cardiac Output
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clearsight measurements All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements |
Outcome Measures
Primary Outcome Measures
- The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline [at baseline, at 1,2,5 (15L),7 and 10 minutes (flush o2)]
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.
Secondary Outcome Measures
- The change in heart rate (BPM) after respectively 15L/min and flush rate preoxygenation in respect to baseline [at baseline, at 1,2,5, (15L o2) and 7, 10 minutes (flush o2)]
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.
- the change in systolic blood pressure (mmHg) after respectively 15L/min and flush rate preoxygenation in respect to baseline [at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)]
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.
- The change in stroke volume (ml) after respectively 15L/min and flush rate preoxygenation in respect to baseline [at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)]
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.
- the change in total peripheral vascular resistance after respectively 15L/min and flush rate preoxygenation in respect to baseline [at baseline, at 1,2,5 (15L o2) and 7,10 minutes (flush o2)]
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.
- The relation of the difference in CI with the occurrence of of haemodynamic sedation events [at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Exclusion Criteria:
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- Cardiogenic shock (SBP<90 mmHg)
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Procedural sedation for cardioversion
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Pregnancy
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General contra-indications for the procedural sedation according to local sedation protocol of the MCL.
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Hypoxia (sat <90% or pO2 <8)) despite oxygen suppletion
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Age < 18 years
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Non-invasive ventilation (NIV) or intubation
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No informed consent
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Use of bleomycin
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COPD GOLD III of IV
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COPD GOLD I of II with hypercapnia (PCO2 > 6,4 kPa)
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Patients in whom no reliable signal for Clearsight measurement can be obtained
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Center Leeuwarden | Leeuwarden | Netherlands | 8934AD |
Sponsors and Collaborators
- Medical Centre Leeuwarden
Investigators
- Principal Investigator: Ewoud ter Avest, MD, PhD, Medical Center Leeuwarden
- Principal Investigator: Renate Stolmeijer, MD, Medical Center Leeuwarden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- nWMO270