The Effect of Hyperoxia on Cardiac Output

NCT03930979 | Completed

• 1 other identifier: nWMO270
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia; Cardiac Output, Low

Keywords

Procedural sedation; Cardiac output measurements non-invasive; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Clearsight measurements

All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

MeSH Terms

Conditions

Hyperoxia; Cardiac Output, Low; Emergencies

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Ewoud ter Avest, MD, PhD

  medical center leeuwarden

  PRINCIPAL INVESTIGATOR

• Renate Stolmeijer, MD

  medical center leeuwarden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: April 29, 2019
• Study Start: May 1, 2018
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: June 26, 2020

Record last verified: 2019-08

Locations

NL (1)