The Effect of Hyperoxia on Cardiac Output

Study Overview
=================
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.

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.

Official Title
-----------------
The Effect of Hyperoxia on Cardiac Output in Patients Undergoing Procedural Sedation in the Emergency Department.

Conditions
-----------------
Hyperoxia, Cardiac Output, Low

Participation Criteria
=================
Eligibility 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: - Cardiogenic shock (SBP<90 mmHg) Procedural sedation for cardioversion Pregnancy General contra-indications for the procedural sedation according to local sedation protocol of the MCL. Hypoxia (sat <90% or pO2 <8)) despite oxygen suppletion Age < 18 years Non-invasive ventilation (NIV) or intubation No informed consent Use of bleomycin COPD GOLD III of IV COPD GOLD I of II with hypercapnia (PCO2 > 6,4 kPa) Patients in whom no reliable signal for Clearsight measurement can be obtained

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clearsight measurements<br>All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at baseline, at 1,2,5 (15L),7 and 10 minutes (flush o2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procedural sedation, Cardiac output measurements non-invasive, Emergency department