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AzTrials

AnesthesiaQUANCANNCT03071432

QUANtification of Cardiovascular Autonomic Neuropathy (CAN) and the Effects of Anaesthesia on Haemodynamics and Cerebral Perfusion

A study testing Paced breathing at 6, 10 and 15 breaths per minute in people with Anesthesia and Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

Rationale: Complications of chronic hyperglycaemia associated with Diabetes Mellitus type 2 (DM2) include macro- and microvascular angiopathy. Cerebral Autoregulation (CA), the capability of the brain to maintain constant cerebral blood flow (CBF) despite changes in blood pressure, is impaired early in DM2 implicating… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Diabetes Mellitus, Type 2
What is being tested?
Paced breathing at 6, 10 and 15 breaths per minute
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteNetherlands
Study dates
30 Aug 2016to 8 Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent
  • Scheduled for elective, non-cardiothoracic surgery under general anesthesia
  • Age 18 years and above

Who cannot join

  • Day case surgery
  • laparoscopic procedure
  • DM type 1
  • Parkinson's disease
  • uncontrolled cardiac arrhythmia
  • Pure autonomic failure (formerly called idiopathic orthostatic hypotension)
Show all 15Show fewer
  • Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome)
  • Addison's disease and hypopituitarism
  • pheochromocytoma
  • peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy)
  • known cardiomyopathy
  • extreme left ventricle hypertrophy or ejection fraction < 30%
  • proven or suspected allergy for any of the medication used during induction of anaesthesia
  • malignant hyperthermia
  • unability to record transcranial doppler ultrasound due to anatomical variance.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic Medical Center

    Amsterdam, North Holland, 1105AZ

Other trials in Netherlands

About this study

Rationale: Complications of chronic hyperglycaemia associated with Diabetes Mellitus type 2 (DM2) include macro- and microvascular angiopathy. Cerebral Autoregulation (CA), the capability of the brain to maintain constant cerebral blood flow (CBF) despite changes in blood pressure, is impaired early in DM2 implicating that CBF becomes dependent on blood pressure. In addition, 20-60% of all patients with DM2 suffers from cardiovascular autonomic neuropathy (CAN) resulting in more unstable blood pressure regulation. In patients without DM2 or CAN, induction of anaesthesia results in slightly decreased blood pressure, but cerebral perfusion is maintained through CA. In contrast, patients with DM2 and CAN may display greater reductions in blood pressure and cerebral perfusion may become jeopardized due to impaired CA. This could be an explanation for the increased incidence of stroke in patients with DM2.

Objective:

Read more
  1. To study whether peri-operative haemodynamics fluctuate more in patients with DM2 and CAN.
  2. To study whether CAN further worsens cerebral perfusion in addition to impaired CA.

Study design: Prospective, observational cohort trial. Study population: A total of 45 patients, 30 with DM2 and 15 healthy controls scheduled for elective, non-cardiothoracic surgery under general anesthesia and age 18 years and above will be included in the study. After inclusion, DM2-patients will be categorized in two groups (both 15 patients): patients with and patients without CAN. Given the prevalence of 20-60% CAN, we plan to screen at most 100 patients and include 15 patients in each study group.

Intervention (if applicable):

  1. PRE-operative: chart review, short physical examination, autonomic function tests to determine the presence of CAN. These tests are simple physiological tests that can be performed on a regular ward and involve a Vasalva manoeuvre, 3 minute paced breathing with a frequency of 6·min-1 and tests for orthostatic hypotension. Also, we test the sensitivity of the cerebral vasculature to CO2 by measuring during one-minute hyperventilation and one minute CO2-rebreathing. Continuous blood pressure monitoring will be obtained using ccNexfin, a non-invasive monitor that comprises a single inflatable finger cuff. Cerebral perfusion will be assessed non-invasively using transcranial Doppler attached with a headband to the temporal skin area and (non-invasive) measurement of cerebral oxygenation using near-infrared spectroscopy (NIRS).
  2. INTRA-operative: we repeat the 3 minute paced breathing test and the CO2-reactivity test.

Main study parameters/endpoints: Between group difference in haemodynamic parameters and cerebral perfusion parameters.

Being tested
Paced breathing at 6, 10 and 15 breaths per minute
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paced breathing at 6, 10 and 15 breaths per minuteDiagnostic test

Study groups in NCT03071432
Study groupRoleWhat they receive
Non-diabetic patientsActive comparatorStudy interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.
Receives: Diagnostic Test: Paced breathing at 6, 10 and 15 breaths per minute
Diabetic patients with cardiovascular autonomic neuropathyActive comparatorStudy interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.
Receives: Diagnostic Test: Paced breathing at 6, 10 and 15 breaths per minute
Diabetic patients without cardiovascular autonomic neuropathyActive comparatorStudy interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.
Receives: Diagnostic Test: Paced breathing at 6, 10 and 15 breaths per minute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in baroreflex sensitivty after induction of anesthesia

    Baroreflex sensitivity (BRS; expressed as ms change in R-R-interval per mmHg blood pressure change) can be seen as a measure of hemodynamic homeostatic control. We calculate BRS preoperatively (baseline) and compare it to intra-operative values (after induction of anesthesia).

    Measured: Pre-operative versus Intra-operative

  2. Change from baseline in dynamic cerebral autoregulation after induction of anesthesia

    Dynamic Cerabral Autoregulation (dCA; expressed as MCAVmean-to-MAP phase lead) can be seen as the ability of the brain to compensate for blood pressure changes. We calculate dCA pre-operatively (baseline) and compare it to intra-operative values (after induction of anesthesia).

    Measured: Pre-operative versus Intra-operative

Secondary outcomes (1)

  1. Clinical outcome

    The relationship between autonomic function tests and clinical outcome during 30-postoperative days (observational). Outcome measures include frequency of all adverse and serious adverse events.

    Measured: Intra-operative till 30 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2017
  2. Study start30 Aug 2016
  3. Primary completion7 Sep 2017
  4. Study completion8 Sep 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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-diabetic patients, n=15 Diabetic patients with cardiovascular autonomic neuropathy, n=15 Diabetic patients without cardiovascular autonomic neuropathy, n=15
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03071432
Sponsor's protocol ID
MEC2016_116
Acronym
QUANCAN
Status last verified
Jan 2018
First submitted
20 Feb 2017
Last updated
1 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sperna Weiland NH, Hermanides J, van der Ster BJP, Hollmann MW, Preckel B, Stok WJ, van Lieshout JJ, Immink RV. Sevoflurane based anaesthesia does not affect already impaired cerebral autoregulation in patients with type 2 diabetes mellitus. Br J Anaesth. 2018 Dec;121(6):1298-1307. doi: 10.1016/j.bja.2018.07.037. Epub 2018 Sep 6.

    PubMed 30442257

  • Sperna Weiland NH, Hermanides J, Hollmann MW, Preckel B, Stok WJ, van Lieshout JJ, Immink RV. Novel method for intraoperative assessment of cerebral autoregulation by paced breathing. Br J Anaesth. 2017 Dec 1;119(6):1141-1149. doi: 10.1093/bja/aex333.

    PubMed 29028933

Questions about this trial

What is this clinical trial studying?

A study testing Paced breathing at 6, 10 and 15 breaths per minute in people with Anesthesia and Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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 1 Feb 2018. 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 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?

Change from baseline in baroreflex sensitivty after induction of anesthesia (time frame: Pre-operative versus Intra-operative). The study lists 2 primary outcomes in all. 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 NCT03071432, which also lists 2 linked publications.

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 Feb 2018.

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