The Effect of Hyperoxia on Cardiac Output

Completed

• Conditions: Hyperoxia; Cardiac Output, Low

• Registration Number: NCT03930979
• Lead Sponsor: Medical Centre Leeuwarden

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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2019-08
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands