Perfusion Index and Pleth Variability IndexPI-PVINCT01389011
Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery
An observational study of Perfusion Index and Pleth Variability Index and Interscalene Blocks, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to: 1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perfusion Index and Pleth Variability Index, Interscalene Blocks, Orthopedic Surgery
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery of the shoulder and the upper arm.
Who may be able to join
- patients scheduled for shoulder or upper arm surgery
- ASA 1-3
- written informed consent
- approval from the local ethics committee
Who cannot join
- arrhythmia
- patients suffering from severe vascular disease, coronary artery (CCS IV) disease
- anaemia (haemoglobin < 7mg/dl)
- patients in whom a tidal volume of 8ml/kg cannot be delivered safely
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery
The purpose of this study is to:
- To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.
- To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.
- Keywords
- PI, PVI, Interscalene block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perfusion Index and Pleth Variability IndexStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389011
- Sponsor's protocol ID
- AS_001
- Acronym
- PI-PVI
- Status last verified
- Jul 2011
- First submitted
- 5 Jul 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
PubMed 23055034
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01389011
- Acronym / sponsor ID
- PI-PVI / AS_001
- Keywords
- PI, PVI, Interscalene block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2010
- First posted
- 7 Jul 2011 (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.
The purpose of this study is to:
- To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.
- To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery of the shoulder and the upper arm.
Key inclusion criteria (4 listed)
- patients scheduled for shoulder or upper arm surgery
- ASA 1-3
- written informed consent
- approval from the local ethics committee
Key exclusion criteria (4 listed)
- arrhythmia
- patients suffering from severe vascular disease, coronary artery (CCS IV) disease
- anaemia (haemoglobin < 7mg/dl)
- patients in whom a tidal volume of 8ml/kg cannot be delivered safely
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
Not reported in the source record.
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 7 Sep 2011.
- Derived from this study: PubMed 23055034Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Perfusion Index and Pleth Variability Index and Interscalene Blocks, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 4 inclusion and 4 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 7 Sep 2011. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389011, which also lists 1 linked publication.
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 7 Sep 2011.