Surgical Procedure, UnspecifiedNCT01928875
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
A study testing AoA Monitoring and Routine (Standard) Anesthesia Monitoring in people with Surgical Procedure, Unspecified, run by GE Healthcare at 4 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- AoA Monitoring and Routine (Standard) Anesthesia Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2013to 1 Feb 2017
- Phase
- Interventional
- 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
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 14155:2011
- 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
Show all 17Show fewer
- Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
- Mean blood pressure below 60 mmHg or above 100 mmHg
- 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
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- AoA Monitoring, Routine (Standard) Anesthesia Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AoA MonitoringDevice
Monitoring with Entropy and SPI parameters during surgery
Routine (Standard) Anesthesia MonitoringDevice
Standard of care monitoring
| Study group | Role | What they receive |
|---|---|---|
| Adequacy of Anesthesia (AoA) Monitoring | Experimental | Adequacy of Anesthesia monitoring with SPI and Entropy Receives: Device: AoA Monitoring |
| Routine (Standard) Anesthesia Monitoring | Active comparator | Not described Receives: Device: Routine (Standard) Anesthesia Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hemodynamic instability
Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia
Measured: Participants will be followed for the duration of their surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startDec 2013
- Primary completion1 Feb 2017
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 Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928875
- Sponsor's protocol ID
- 123.04-2012-GES-0009
- Status last verified
- Apr 2017
- First submitted
- 19 Aug 2013
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruenewald M, Harju J, Preckel B, Molnar Z, Yli-Hankala A, Rosskopf F, Koers L, Orban A, Bein B; AoA Study Group. Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial. Eur J Anaesthesiol. 2021 Jan;38(1):73-81. doi: 10.1097/EJA.0000000000001357.
PubMed 33074943
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
- ClinicalTrials.gov ID
- NCT01928875
- Acronym / sponsor ID
- 123.04-2012-GES-0009
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- 1 Feb 2017 (actual)
- First posted
- 27 Aug 2013 (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 demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adequacy of Anesthesia (AoA) Monitoring | Experimental | Device: AoA MonitoringAdequacy of Anesthesia monitoring with SPI and Entropy |
| Routine (Standard) Anesthesia Monitoring | Active comparator | Device: Routine (Standard) Anesthesia Monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011
- 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
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 |
|---|---|---|
| AoA MonitoringMonitoring with Entropy and SPI parameters during surgery | Device | Adequacy of Anesthesia (AoA) Monitoring |
| Routine (Standard) Anesthesia MonitoringStandard of care monitoring | Device | Routine (Standard) Anesthesia Monitoring |
Primary outcome
Incidence of hemodynamic instability
Time frame: Participants will be followed for the duration of their surgery
Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia
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 1 May 2017.
- Derived from this study: PubMed 33074943Gruenewald M, Harju J, Preckel B, Molnar Z, Yli-Hankala A, Rosskopf F, Koers L, Orban A, Bein B; AoA Study Group. Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial. Eur J Anaesthesiol. 2021 Jan;38(1):73-81. doi: 10.1097/EJA.0000000000001357.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AoA Monitoring and Routine (Standard) Anesthesia Monitoring in people with Surgical Procedure, Unspecified, run by GE Healthcare at 4 sites in 4 countries.
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 17 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 1 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 4 sites in Finland, Germany, Hungary, 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?
Incidence of hemodynamic instability (time frame: Participants will be followed for the duration of their surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928875, 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 1 May 2017.