Anesthesia,GeneralNCT01467167
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
An observational study of Anesthesia,General, run by University Medical Center Groningen at 2 sites in 2 countries.
Trial summary
Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia,General
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2011to Oct 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.
Who may be able to join
- Elective surgery
- General anesthesia
- American Society of Anesthesiologists Physical Status: I - III
- Age 18 to 90 years
Who cannot join
- Combined regional and general anesthesia
- Expected surgery duration < 30 minutes
- Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
- Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
- Heart surgery on cardio-pulmonary bypass
- Relevant hepatic disease (Child B or higher)
Show all 9Show fewer
- BMI >35
- Overt signs of alcohol abuse
- Contraindications or allergies to drugs used in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.
- Conditions
- Anesthesia,General
- Keywords
- Anesthesia, Smart Pilot View, Pain control, Recovery
- Medical subject headings
- Agnosia
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 |
|---|---|---|
| Baseline | Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice. | |
| Smart Pilot View Group | Study group in which patients are anesthetized with the use of Smart Pilot View. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Quality Score
Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg.
Measured: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Secondary outcomes (7)
Total anesthetic drug doses
Measured: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Mean intra-operative Noxious Stimulation Response Index (NSRI)
The Noxious Stimulation Response Index (NSRI) is based on a hierarchical interaction propofol-remifentanil model. With this model, the predicted propofol and remifentanyl concentrations can make a prediction about a respons to a certain stimulus, such as shaking and shouting, or a noxious stimulus.
Measured: 1 day During surgery (until skin closure)
Number of doses of vasoactive substances
The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.
Measured: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Number of events with motor and vegetative (tearing, sweating) responses
The total number of events in which the patient displays vegetative reactions such as tearing and sweating, in respons to a noxious stimulus during surgery.
Measured: up to 1 week From start of induction until discharge from post-anesthesia care unit
Recovery times (skin closure to extubation; skin closure to orientation)
The time it takes for the patient to recover from anesthesia: the time from skin closure until the patient is sufficiently awake to be extubated, and the time from skin closure until full orientation of the patient.
Measured: up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Early postoperative pain control measured by visual analog scale and total morphine dose
Assess the adequacy of pain control during the early postoperative stage, measured by the visual analog scale and the total dose of morphine immediately postoperatively and during PACU stay.
Measured: up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Workload of anesthesist, measured by the NASA Taskload Index
Assess the workload the anesthetist experiences while working with the Smart Pilot View
Measured: up to 1 day From start of induction until transportation to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2017
- Study completionOct 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 Anesthesia,GeneralStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467167
- Sponsor's protocol ID
- SPV_Utility_V7
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2011
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.
PubMed 35361490
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01467167
- Acronym / sponsor ID
- SPV_Utility_V7
- Conditions
- Anesthesia,General
- Keywords
- Anesthesia, Smart Pilot View, Pain control, Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Oct 2011
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 8 Nov 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.
Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | –Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice. |
| Smart Pilot View Group | – | –Study group in which patients are anesthetized with the use of Smart Pilot View. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.
Key inclusion criteria (4 listed)
- Elective surgery
- General anesthesia
- American Society of Anesthesiologists Physical Status: I - III
- Age 18 to 90 years
Key exclusion criteria (9 listed)
- Combined regional and general anesthesia
- Expected surgery duration < 30 minutes
- Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
- Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
- Heart surgery on cardio-pulmonary bypass
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
Anesthesia Quality Score
Time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg.
7 secondary outcomes
Total anesthetic drug doses
Time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Mean intra-operative Noxious Stimulation Response Index (NSRI)
Time frame: 1 day During surgery (until skin closure)
Number of doses of vasoactive substances
Time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Number of events with motor and vegetative (tearing, sweating) responses
Time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit
Recovery times (skin closure to extubation; skin closure to orientation)
Time frame: up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Early postoperative pain control measured by visual analog scale and total morphine dose
Time frame: up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Workload of anesthesist, measured by the NASA Taskload Index
Time frame: up to 1 day From start of induction until transportation to PACU
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 Apr 2024.
- Derived from this study: PubMed 35361490Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia,General, run by University Medical Center Groningen at 2 sites in 2 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 4 inclusion and 9 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. 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?
Anesthesia Quality Score (time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)). 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 NCT01467167, 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 17 Apr 2024.