Postoperative DeliriumNCT03148730
Manual vs Automated Anesthesia : Impact On The Incidence Of POCD
A study testing closed-loop group in people with Postoperative Delirium, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This study will be the first study to report the combined use of three independent closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid and optimize ventilation in frailty old patients undergoing moderate to high risk surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- closed-loop group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2017to 21 Nov 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > or equal 60 years old
- ASA score I-III
- Scheduled for non cardiac surgery under total intravenous anesthesia
- Self sufficient (living at home or in non medical institution)
- MOCA test preop > 23/30
- No Stroke, alzeihmer, Parkinson disease
- Written informed consent signed
Who cannot join
- Allergy to propofol or remifentanil
- MOCA test < 23/30
- Visual or hearing deficiency
- Atrial fibrillation, or other Contra indication to the use of dynamic parameters of fluid responsiveness.
- Chronic renal failure ( creatinin level maximum at 2 mg/ml; no dialysis)
- Large liver resection : our center has a strict fluid /CVP fluid restriction in place
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual vs Automated Optimization of Anesthesia, Analgesia, Fluid Management and Ventilation Using Closed-loop Systems: Impact On The Incidence Of POCD In Elderly Patients Undergoing Moderate to High Risk Surgery
This study will be the first study to report the combined use of three independent closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid and optimize ventilation in frailty old patients undergoing moderate to high risk surgery. The potential benefits of optimizing the control of these variables by advanced closed loop systems are two-fold. Firstly, this will likely decrease the variance of delivered care and reduce deviation from the established standards, resulting in improved post operative cognitive outcomes in elderly patients. Secondly, this would establish a precedent that automated intraoperative systems have strong clinical significance and are more than "complicated toys", which is unfortunately how they are perceived now.
Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk surgery (Better MOCA test in the postoperative period compared to the manual group [+ two points in average])
Read the detailed description
Elderly patients comprise more than 40% of all surgical patients in the USA per year and generate an even larger proportion of total healthcare costs with a sizable amount occurring during the postoperative period 1.. Therefore, reducing postoperative morbidity and mortality is a major concern in clinical practice and medical research moving forward. Cognitive dysfunction and dependence on caregivers represents two major risk factors in the elderly, especially following general anesthesia. The current literature indicates that POCD results in a mortality rate of 10% at 6 months for patients at least 70 years old and causes loss of functional capacity in an additional 20%. Overall, this results in an approximately 1 of 3 patients experiencing a negative cognitive impact following general anesthesia without optimization of anesthetic depth. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of postoperative impairments by via improved control of the anesthetic depth, especially over-sedation.
Despite steady improvements in surgical safety throughout recent years, the application of perioperative therapies still has the potential to be improved, especially regarding compliance to evidence-based recommendations.2, 3 Specifically, simply being surrounded by established monitors does not ensure that proper therapies are delivered most effectively or consistently to all patients - there must also be appropriate and timely interventions. Concordantly, large variations in patient care still exist and have been correlated with large variations in patient outcomes.4 Looking at the safety record that automation has achieved in fields ranging from manufacturing to commercial flight, medical researchers have developed devices utilizing self-contained feedback technologies (CLS) in an attempt to decrease the variability in treatment delivery with the ultimate goal of improving patient care. This development has flourished within anesthesiology, mainly via physiological closed-loop controlled devices. These systems are able to automatically adjust a therapeutic intervention based on continuous feedback from various physiological sensors.5 The best described systems have been closed-loop delivery of anesthetics, analgesics,6-11 volatile agents, insulin, and most recently, fluids 5, 12-14 and vasopressors.15-17 Overall, these systems have been shown to improve the consistency of intervention when compared to manual administration.10, 18, 19 Additionally, computer-assistance for clinical care will allow anesthesia providers to increase their accuracy and consistency, improve their awareness, and allow them to instead focus on more complex tasks.
Over the past years, members of our group have developed a dual closed-loop controller allowing the automated titration of propofol and remifentanil guided by the bispectral index (BIS).11, 20-22 The investigators also have created an adaptative closed-loop system for fluid titration using goal directed fluid therapy (GDFT) strategies guided by a minimally invasive cardiac output monitor.5 The investigator has previously demonstrated the superiority of a controller versus human-guided anesthesia in maintaining a target of BIS between 40 and 60 while limiting the incidence of overly deep anesthesia, which is often associated with the occurrence of a cognitive dysfunction in the elderly 23 Very recently, the principal investigator submitted research evaluating the simultaneous use of 2 closed-loop system (anesthesia, analgesia and fluid management) in a pilot study of high risk vascular patients.
Objectives: The main objective of this prospective randomized single-blinded controlled study is to compare manual versus automated administration of anesthesia, analgesia, fluid and ventilation with regard to the incidence of postoperative cognitive dysfunction (POCD) in elderly patients undergoing high risk surgery. POCD will be assessed by a psychiatrist and/or a psychologist preoperatively, on postoperative day 3-10 (depending on the type of surgery) and at 3-months postoperatively. Additionally, quality of life and quality of recovery will also be self-assessed before surgery, before hospital discharge and at 3 month post-surgery.
- Conditions
- Postoperative Delirium
- Being tested
- closed-loop group
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop groupDevice
Use of 3 indenpendent closed-loop systems to deliver the propofol, remifentanil, fluid and to adjust ventilation
| Study group | Role | What they receive |
|---|---|---|
| manual group | No intervention | This group will have a standard of care anesthesia. All the drugs, fluid and adjustement of ventilation settings will be done manually by the supervising anesthesiologist using the same drugs and fluids as the closed-loop group |
| automated closed-loop group | Experimental | This group will have a fully automated anesthesia, analgesia , ventilation and fluid management using 3 indenpendent closed-loop systems same drugs used in both groups ( propofol and remifentanil, Plasmalyte and /or Voluven) Receives: Device: closed-loop group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction (POCD)
assessment of the POCD using the MOCA test ( done by a psychiatrist and a psychologist). This will be done preoperatively, at postoperative day 3-5 for moderate risk surgery and postoperative day 7-10 for high risk surgery
Measured: first month
Secondary outcomes (19)
Assesment of the incidence of POCD using different others tests:
- assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done day the before surgery
Measured: Before Surgery
Assesment of the incidence of POCD using different others tests:
- assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done on postoperative day 3-5 (for moderate risk surgery)
Measured: day 5 after surgery
Assesment of the incidence of POCD using different others tests:
- assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done on postoperative day 7-10 for high risk surgery
Measured: day 10 after surgery
Long term incidence of POCD
results of the MOCA test
Measured: month 3 post surgery
Assessment of the Quality of life EQ-5D-5L
self assessment by the patient: done the day before surgery and at month 3 post surgery
Measured: 3 months
Assessment of Quality of recovery (QoR)
self assessment by the patient: QoR-15 items: questionnaire done before surgery to provide baseline data and then repeated after surgery (post operative day 3 for moderate risk surgery and postoperative day 7for high risk surgery).
Measured: first month
Amount of i.v drugs used ( propofol, remifentanil, vasopressors)
amount of iv drugs used during the surgery
Measured: first 24 hours
Amount of total fluid infused to the patient
comparison of the amount of fluid administered to the patients between groups
Measured: first 24 hours
Mean BIS values and Burst suppression ratio (BSR) incidence defined as a period of isoelectric cortical signal with a treshold at 10% for > 1 minutes.
comparison of the mean BIS values and occurrence of BSR between groups
Measured: first 24 hours
mean arterial pressure (MAP) during surgery
comparison of the mean values of these variables between both groups
Measured: first 24 hours
Mean : mean stroke volume, stroke volume variation and cardiac output and cardiac index
comparison of the mean values of these variables between both groups
Measured: first 24 hours
Incidence of postoperative complications (major and minor)
comparison of the incidence of postoperative complications between both groups
Measured: From date of surgery until day 30 after surgery
Length of stay in the intensive care unit (ICU) and/or postanesthesia care unit (PACU)
comparison of the length of stay between both groups
Measured: From date of surgery until the date of Postanesthesia or intensive care setting discharge or date of death from any cause assessed up to 100 weeks after surgery
Length of stay in the hospital (
comparison of the hospital length of stay between both groups
Measured: From date of surgery until the date of hopital discharge or date of death from any cause assessed up to 100 weeks after surgery
Mortality at day 30
death at 1 month
Measured: 30 days
Mortality at month 3
death at 3 months
Measured: 3 months
Comparison of performance of the automated system vs the manual group
defined as the time of the surgery spent with a BIS values [40-60] and a SVV <13% and/or a CI > 2.5 l/min/m2 for
Measured: first 24 hours
Occurrence of arterial hypotension (mean arterial pressure (MAP) < 65 mmHg)
MAP < 65 mmHg
Measured: first 24 hours
Occurrence of awarness
questionnaire
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start10 May 2017
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups one = manually conducted anesthesia second = fully automated anesthesia, analgesia, ventilation and fluid management
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Alexandre Joosten, M.D, Principal investigator, Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148730
- Sponsor's protocol ID
- P2015/539 / B406201526591
- Status last verified
- Jan 2020
- First submitted
- 1 May 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual vs Automated Optimization of Anesthesia, Analgesia, Fluid Management and Ventilation Using Closed-loop Systems: Impact On The Incidence Of POCD In Elderly Patients Undergoing Moderate to High Risk Surgery
- ClinicalTrials.gov ID
- NCT03148730
- Acronym / sponsor ID
- P2015/539 / B406201526591
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
This study will be the first study to report the combined use of three independent closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid and optimize ventilation in frailty old patients undergoing moderate to high risk surgery. The potential benefits of optimizing the control of these variables by advanced closed loop systems are two-fold. Firstly, this will likely decrease the variance of delivered care and reduce deviation from the established standards, resulting in improved post operative cognitive outcomes in elderly patients. Secondly, this would establish a precedent that automated intraoperative systems have strong clinical significance and are more than "complicated toys", which is unfortunately how they are perceived now.
Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk surgery (Better MOCA test in the postoperative period compared to the manual group [+ two points in average])
Detailed description
Elderly patients comprise more than 40% of all surgical patients in the USA per year and generate an even larger proportion of total healthcare costs with a sizable amount occurring during the postoperative period 1.. Therefore, reducing postoperative morbidity and mortality is a major concern in clinical practice and medical research moving forward. Cognitive dysfunction and dependence on caregivers represents two major risk factors in the elderly, especially following general anesthesia. The current literature indicates that POCD results in a mortality rate of 10% at 6 months for patients at least 70 years old and causes loss of functional capacity in an additional 20%. Overall, this results in an approximately 1 of 3 patients experiencing a negative cognitive impact following general anesthesia without optimization of anesthetic depth. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of postoperative impairments by via improved control of the anesthetic depth, especially over-sedation.
Despite steady improvements in surgical safety throughout recent years, the application of perioperative therapies still has the potential to be improved, especially regarding compliance to evidence-based recommendations.2, 3 Specifically, simply being surrounded by established monitors does not ensure that proper therapies are delivered most effectively or consistently to all patients - there must also be appropriate and timely interventions. Concordantly, large variations in patient care still exist and have been correlated with large variations in patient outcomes.4 Looking at the safety record that automation has achieved in fields ranging from manufacturing to commercial flight, medical researchers have developed devices utilizing self-contained feedback technologies (CLS) in an attempt to decrease the variability in treatment delivery with the ultimate goal of improving patient care. This development has flourished within anesthesiology, mainly via physiological closed-loop controlled devices. These systems are able to automatically adjust a therapeutic intervention based on continuous feedback from various physiological sensors.5 The best described systems have been closed-loop delivery of anesthetics, analgesics,6-11 volatile agents, insulin, and most recently, fluids 5, 12-14 and vasopressors.15-17 Overall, these systems have been shown to improve the consistency of intervention when compared to manual administration.10, 18, 19 Additionally, computer-assistance for clinical care will allow anesthesia providers to increase their accuracy and consistency, improve their awareness, and allow them to instead focus on more complex tasks.
Over the past years, members of our group have developed a dual closed-loop controller allowing the automated titration of propofol and remifentanil guided by the bispectral index (BIS).11, 20-22 The investigators also have created an adaptative closed-loop system for fluid titration using goal directed fluid therapy (GDFT) strategies guided by a minimally invasive cardiac output monitor.5 The investigator has previously demonstrated the superiority of a controller versus human-guided anesthesia in maintaining a target of BIS between 40 and 60 while limiting the incidence of overly deep anesthesia, which is often associated with the occurrence of a cognitive dysfunction in the elderly 23 Very recently, the principal investigator submitted research evaluating the simultaneous use of 2 closed-loop system (anesthesia, analgesia and fluid management) in a pilot study of high risk vascular patients.
Objectives: The main objective of this prospective randomized single-blinded controlled study is to compare manual versus automated administration of anesthesia, analgesia, fluid and ventilation with regard to the incidence of postoperative cognitive dysfunction (POCD) in elderly patients undergoing high risk surgery. POCD will be assessed by a psychiatrist and/or a psychologist preoperatively, on postoperative day 3-10 (depending on the type of surgery) and at 3-months postoperatively. Additionally, quality of life and quality of recovery will also be self-assessed before surgery, before hospital discharge and at 3 month post-surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups one = manually conducted anesthesia second = fully automated anesthesia, analgesia, ventilation and fluid management
| Arm | Type | Receives |
|---|---|---|
| manual group | No intervention | –This group will have a standard of care anesthesia. All the drugs, fluid and adjustement of ventilation settings will be done manually by the supervising anesthesiologist using the same drugs and fluids as the closed-loop group |
| automated closed-loop group | Experimental | Device: closed-loop groupThis group will have a fully automated anesthesia, analgesia , ventilation and fluid management using 3 indenpendent closed-loop systems same drugs used in both groups ( propofol and remifentanil, Plasmalyte and /or Voluven) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients > or equal 60 years old
- ASA score I-III
- Scheduled for non cardiac surgery under total intravenous anesthesia
- Self sufficient (living at home or in non medical institution)
- MOCA test preop > 23/30
Key exclusion criteria (6 listed)
- Allergy to propofol or remifentanil
- MOCA test < 23/30
- Visual or hearing deficiency
- Atrial fibrillation, or other Contra indication to the use of dynamic parameters of fluid responsiveness.
- Chronic renal failure ( creatinin level maximum at 2 mg/ml; no dialysis)
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 |
|---|---|---|
| closed-loop groupUse of 3 indenpendent closed-loop systems to deliver the propofol, remifentanil, fluid and to adjust ventilation | Device | automated closed-loop group |
Primary outcome
Incidence of postoperative cognitive dysfunction (POCD)
Time frame: first month
assessment of the POCD using the MOCA test ( done by a psychiatrist and a psychologist). This will be done preoperatively, at postoperative day 3-5 for moderate risk surgery and postoperative day 7-10 for high risk surgery
19 secondary outcomes
Assesment of the incidence of POCD using different others tests:
Time frame: Before Surgery
Assesment of the incidence of POCD using different others tests:
Time frame: day 5 after surgery
Assesment of the incidence of POCD using different others tests:
Time frame: day 10 after surgery
Long term incidence of POCD
Time frame: month 3 post surgery
Assessment of the Quality of life EQ-5D-5L
Time frame: 3 months
Assessment of Quality of recovery (QoR)
Time frame: first month
Amount of i.v drugs used ( propofol, remifentanil, vasopressors)
Time frame: first 24 hours
Amount of total fluid infused to the patient
Time frame: first 24 hours
Mean BIS values and Burst suppression ratio (BSR) incidence defined as a period of isoelectric cortical signal with a treshold at 10% for > 1 minutes.
Time frame: first 24 hours
mean arterial pressure (MAP) during surgery
Time frame: first 24 hours
Mean : mean stroke volume, stroke volume variation and cardiac output and cardiac index
Time frame: first 24 hours
Incidence of postoperative complications (major and minor)
Time frame: From date of surgery until day 30 after surgery
Length of stay in the intensive care unit (ICU) and/or postanesthesia care unit (PACU)
Time frame: From date of surgery until the date of Postanesthesia or intensive care setting discharge or date of death from any cause assessed up to 100 weeks after surgery
Length of stay in the hospital (
Time frame: From date of surgery until the date of hopital discharge or date of death from any cause assessed up to 100 weeks after surgery
Mortality at day 30
Time frame: 30 days
Mortality at month 3
Time frame: 3 months
Comparison of performance of the automated system vs the manual group
Time frame: first 24 hours
Occurrence of arterial hypotension (mean arterial pressure (MAP) < 65 mmHg)
Time frame: first 24 hours
Occurrence of awarness
Time frame: first 24 hours
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 28 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Alexandre Joosten, M.D principal investigator
Erasme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed-loop group in people with Postoperative Delirium, run by Erasme University Hospital at 1 site in Belgium.
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 7 inclusion and 6 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 28 Jan 2020. 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 Belgium. 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 postoperative cognitive dysfunction (POCD) (time frame: first month). 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 28 Jan 2020.