The Effect of Hyperoxia on Cardiac Output

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperoxia; Cardiac Output, Low

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Netherlands
  • Leeuwarden, Netherlands, 8934AD
    • Medical Center Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Clearsight measurements; 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)

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Ewoud ter Avest, MD, PhD, Medical Center Leeuwarden; Principal Investigator: Renate Stolmeijer, MD, Medical Center Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Emergency department; Procedural sedation; Cardiac output measurements non-invasive
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Hyperoxia; Cardiac Output, Low
• Other Study ID Numbers: nWMO270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No