The Effect of Hyperoxia on Cardiac Output

NCT ID: NCT03930979

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-06-07

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.

Conditions

Hyperoxia; Cardiac Output, Low

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clearsight measurements

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frisius Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ewoud ter Avest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

medical center leeuwarden

Renate Stolmeijer, MD

Role: PRINCIPAL_INVESTIGATOR

medical center leeuwarden

Locations

Medical Center Leeuwarden

Leeuwarden, , Netherlands

Countries

Netherlands

Other Identifiers

nWMO270

Identifier Type: -

Identifier Source: org_study_id