The Effect of Hyperoxia on Cardiac Output

Hyperoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930979
• Other study ID #: nWMO270
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: August 2019
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Hyperoxia

Locations

Country	Name	City	State
Netherlands	Medical Center Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)