AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Belgium1 site
  • Erasme

    Brussels, 1070

Other trials in Belgium

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.

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 groups in NCT03148730
Study groupRoleWhat they receive
manual groupNo interventionThis 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 groupExperimentalThis 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.

  1. 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)
  1. Assesment of the incidence of POCD using different others tests:

    1. 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

  2. Assesment of the incidence of POCD using different others tests:

    1. 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

  3. Assesment of the incidence of POCD using different others tests:

    1. 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

  4. Long term incidence of POCD

    results of the MOCA test

    Measured: month 3 post surgery

  5. 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

  6. 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

  7. Amount of i.v drugs used ( propofol, remifentanil, vasopressors)

    amount of iv drugs used during the surgery

    Measured: first 24 hours

  8. Amount of total fluid infused to the patient

    comparison of the amount of fluid administered to the patients between groups

    Measured: first 24 hours

  9. 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

  10. mean arterial pressure (MAP) during surgery

    comparison of the mean values of these variables between both groups

    Measured: first 24 hours

  11. 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

  12. 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

  13. 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

  14. 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

  15. Mortality at day 30

    death at 1 month

    Measured: 30 days

  16. Mortality at month 3

    death at 3 months

    Measured: 3 months

  17. 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

  18. Occurrence of arterial hypotension (mean arterial pressure (MAP) < 65 mmHg)

    MAP < 65 mmHg

    Measured: first 24 hours

  19. 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.

  1. First posted11 May 2017
  2. Study start10 May 2017
  3. Primary completion21 Nov 2017
  4. Study completion21 Nov 2017

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in