Monitoring, PhysiologicalNCT02989441
Perfusion Index in Anesthesia
An observational study of Monitoring, Physiological, run by Jakob Højlund at 1 site in Denmark.
Trial summary
In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monitoring, Physiological
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
Who may be able to join
- Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
- Willingness to participate
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia
In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)
- Conditions
- Monitoring, Physiological
- Keywords
- Perfusion Index, Hemodynamics, Anesthesia, Stroke Volume
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)
Measured: Intra-operative
Secondary outcomes (1)
Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring, PhysiologicalStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakob Højlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakob Højlund, Hvidovre University Hospital
- Investigators
- Nicolai B Foss, MD PhD, Study chair, Hvidovre University Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989441
- Sponsor's protocol ID
- H-16030081
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia
- ClinicalTrials.gov ID
- NCT02989441
- Acronym / sponsor ID
- H-16030081
- Conditions
- Monitoring, Physiological
- Keywords
- Perfusion Index, Hemodynamics, Anesthesia, Stroke Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jakob HøjlundUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Dec 2016 (estimated)
- 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.
In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
Key inclusion criteria (2 listed)
- Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
- Willingness to participate
Key exclusion criteria (1 listed)
- Patient refusal
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
Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)
Time frame: Intra-operative
1 secondary outcome
Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)
Time frame: Intra-operative
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 17 Aug 2018.
- 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.
Nicolai B Foss, MD PhD study chair
Hvidovre University Hospital, University of Copenhagen
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 Monitoring, Physiological, run by Jakob Højlund at 1 site in Denmark.
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 2 inclusion and 1 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 17 Aug 2018. 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 Denmark. 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?
Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV) (time frame: Intra-operative). 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 17 Aug 2018.