HyperoxiaNCT03930979
The Effect of Hyperoxia on Cardiac Output
An observational study of Hyperoxia and Cardiac Output, Low, run by Frisius Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia, Cardiac Output, Low
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 7 Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Who may be able to join
- Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Who cannot join
- - 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hyperoxia on Cardiac Output in Patients Undergoing Procedural Sedation in the Emergency Department.
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.
Read the 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
- Keywords
- Procedural sedation, Cardiac output measurements non-invasive, Emergency department
- Medical subject headings
- Hyperoxia, Cardiac Output, Low, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clearsight measurements | All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewoud ter Avest, MD, PhD, Principal investigator, medical center leeuwardenRenate Stolmeijer, MD, Principal investigator, medical center leeuwarden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930979
- Sponsor's protocol ID
- nWMO270
- Status last verified
- Aug 2019
- First submitted
- 17 Jul 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperoxia on Cardiac Output in Patients Undergoing Procedural Sedation in the Emergency Department.
- ClinicalTrials.gov ID
- NCT03930979
- Acronym / sponsor ID
- nWMO270
- Conditions
- Hyperoxia, Cardiac Output, Low
- Keywords
- Procedural sedation, Cardiac output measurements non-invasive, Emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clearsight measurements | – | –All patients presenting to the ED who have a painful condition for which procedural sedation is required will undergo Clearsight measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Key inclusion criteria (1 listed)
- Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewoud ter Avest, MD, PhD principal investigator
medical center leeuwarden
Renate Stolmeijer, MD principal investigator
medical center leeuwarden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperoxia and Cardiac Output, Low, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.