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Completed

NCT Number: NCT03930979

The Effect of Hyperoxia on Cardiac Output

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.

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Key information

Conditions

Hyperoxia Cardiac Output, Low Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Leeuwarden

Leeuwarden, 8934AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline

    Time frame: 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 outcomes

  1. The change in heart rate (BPM) after respectively 15L/min and flush rate preoxygenation in respect to baseline

    Time frame: 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.

  2. the change in systolic blood pressure (mmHg) after respectively 15L/min and flush rate preoxygenation in respect to baseline

    Time frame: 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.

  3. The change in stroke volume (ml) after respectively 15L/min and flush rate preoxygenation in respect to baseline

    Time frame: 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.

  4. the change in total peripheral vascular resistance after respectively 15L/min and flush rate preoxygenation in respect to baseline

    Time frame: 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.

  5. The relation of the difference in CI with the occurrence of of haemodynamic sedation events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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