AnesthesiaSPIrelevanceNCT02074475
SPI Value Relevance in Clinical Practice
An observational study of Anesthesia, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2013to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients assessed for operation lasting more than two hours and requiring intubation.
Who may be able to join
- Ability to provide written informed consent
- Age 18-80 years of age
- Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube
Who cannot join
- Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011o Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
- Any subject with a cardiac pacemaker
- Any subject with atrial fibrillation at the time of obtaining the baseline values
- Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
- Any subject who needs invasive blood pressure measurement
- Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
Show all 15Show fewer
- o Mean blood pressure below 60 mmHg or above 100 mmHg o HR below 45 /min or above 100/min
- Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
- Any subject having surgery that requires prone position
- Any subject with very high body mass index (>35) because of incompatibility with the target controlled anesthesia models used
- Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
- Any subject with laryngeal mask airway
- Any subject who requires neuromuscular blocking agent infusion
- Any subject who is going to have major surgery with a high risk of extensive blood loss
- Any subject with known chronic use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GE AOA Study Spin-off: Defining the Clinically Useful Range for Surgical Pleth Index
Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. SPI indicates the balance between intensity of surgical stimulation and the level of anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study population will be 150 patients.
Read the detailed description
Signs of non-adequate anaesthesia are motor and/or autonomic nervous system arousals during surgery.
- Conditions
- Anesthesia
- Being tested
- Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
A group of no Monitoring patients from larger AoA study with no adequacy of anaesthesia monitoring
| Study group | Role | What they receive |
|---|---|---|
| Control group | The control group of three sites for larger Adequacy of Anaesthesia study. Total 150 patients Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal maximum limit for SPI
SPI -value at a predefined criteria for signs of anaesthesia.
Measured: 1 day
Secondary outcomes (1)
Optimal lower limit for SPI
The measured lower limit SPI-value at the time point for signs of too deep anaesthesia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jarkko Harju, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074475
- Sponsor's protocol ID
- JH2013-1
- Acronym
- SPIrelevance
- Status last verified
- May 2017
- First submitted
- 19 Dec 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GE AOA Study Spin-off: Defining the Clinically Useful Range for Surgical Pleth Index
- ClinicalTrials.gov ID
- NCT02074475
- Acronym / sponsor ID
- SPIrelevance / JH2013-1
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Feb 2014 (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.
Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. SPI indicates the balance between intensity of surgical stimulation and the level of anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study population will be 150 patients.
Detailed description
Signs of non-adequate anaesthesia are motor and/or autonomic nervous system arousals during surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Control groupThe control group of three sites for larger Adequacy of Anaesthesia study. Total 150 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed for operation lasting more than two hours and requiring intubation.
Key inclusion criteria (3 listed)
- Ability to provide written informed consent
Key exclusion criteria (15 listed)
- Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011o Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
- o Mean blood pressure below 60 mmHg or above 100 mmHg o HR below 45 /min or above 100/min
- Any subject with very high body mass index (>35) because of incompatibility with the target controlled anesthesia models used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupA group of no Monitoring patients from larger AoA study with no adequacy of anaesthesia monitoring | Other | Control group |
Primary outcome
optimal maximum limit for SPI
Time frame: 1 day
SPI -value at a predefined criteria for signs of anaesthesia.
1 secondary outcome
Optimal lower limit for SPI
Time frame: 1 day
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 5 May 2017.
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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.
Jarkko Harju, MD principal investigator
Tampere University Hospital
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 Anesthesia, run by Tampere University Hospital at 1 site in Finland.
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 3 inclusion and 15 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 5 May 2017. 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 Finland. 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?
optimal maximum limit for SPI (time frame: 1 day). 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 5 May 2017.