Clinical trial NCT03930979: The Effect of Hyperoxia on Cardiac Output
Official title: The Effect of Hyperoxia on Cardiac Output in Patients Undergoing Procedural Sedation in the Emergency Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperoxia
Cardiac Output, Low
Keywords: Procedural sedation
Cardiac output measurements non-invasive
Emergency department
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.

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.

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

Primary outcomes:
measure: The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline
timeFrame: at baseline, at 1,2,5 (15L),7 and 10 minutes (flush o2)
Secondary outcomes:
measure: The change in heart rate (BPM) after respectively 15L/min and flush rate preoxygenation in respect to baseline
timeFrame: at baseline, at 1,2,5, (15L o2) and 7, 10 minutes (flush o2)
measure: the change in systolic blood pressure (mmHg) after respectively 15L/min and flush rate preoxygenation in respect to baseline
timeFrame: at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)
measure: The change in stroke volume (ml) after respectively 15L/min and flush rate preoxygenation in respect to baseline
timeFrame: at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2)
measure: the change in total peripheral vascular resistance after respectively 15L/min and flush rate preoxygenation in respect to baseline
timeFrame: at baseline, at 1,2,5 (15L o2) and 7,10 minutes (flush o2)
measure: The relation of the difference in CI with the occurrence of of haemodynamic sedation events
timeFrame: at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2)
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: medical center leeuwarden
name: Ewoud ter Avest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: medical center leeuwarden
name: Renate Stolmeijer, MD
role: PRINCIPAL_INVESTIGATOR
References: