NIR SpectroscopyPhase 4NCT02593448
Influence of Cardiopulmonary Bypass, and Sevoflurane or Propofol Anesthesia, on Tissue Oxygen Saturation.
A Phase 4 study testing NIRS during VOT, General anaesthesia with propofol use and General anaesthesia with sevoflurane use in people with NIR Spectroscopy, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The purpose of the present study is to assess, by near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on tissue saturation in thenar muscle. The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue saturation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NIR Spectroscopy
- What is being tested?
- NIRS during VOT, General anaesthesia with propofol use and General anaesthesia with sevoflurane use
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2012to Aug 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult
- scheduled for elective, open-heart cardiac surgical operation with use of cardiopulmonary bypass.
- signed written consent
Who cannot join
- surgeon's intention to use the radial artery for arterial bypass
- symptoms of peripheral atherosclerosis
- paresis of a limb
- autoimmune disease
- other factors that could potentially affect blood flow in the upper extremities
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Gdansk, Pomeranian Voivodeship, PL 80-211
About this study
Official title: Influence of Cardiopulmonary Bypass and Sevoflurane or Propofol Anesthesia on Tissue Oxygen Saturation of Thenar Muscle in Adults.
The purpose of the present study is to assess, by near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on tissue saturation in thenar muscle.
The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue saturation.
Read more
It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at the following time points: 30 minutes after anaesthesia induction, directly after sternotomy, 20 and 40 minutes after aortic cross-clamping, 20 minutes after aortic cross-clamp removal, and 45 minutes after weaning of cardiopulmonary bypass (CPB).
Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's test.
Read the detailed description
Near-infrared spectroscopy (NIRS) is a modern technique for cardiac surgical patient monitoring. The NIRS method is based on Lambert-Beer's law, which defines the relationship between the concentration of a substance and reduction of the intensity of electro-magnetic radiation. This reduction results from photon absorption by chromatophores, including haemoglobin, myoglobin and cytochrome P1. Absorption at the given wave-length depends on the degree of chromatophore oxygenation, and hence allows for its assessment. NIRS is currently commonly used for the assessment of brain oximetry in thoracic aorta surgery and, increasingly often, in open-heart surgery. Algorithms for sustaining adequate brain saturation were reported to decrease the incidence of neurological complications following cardiac surgery. In recent years, NIRS was proposed as a tool for the assessment of muscle saturation under short-term ischaemia and reperfusion, referred to as the vascular occlusion test (VOT). VOT is a provocative test in which tissue saturation (StO2) is measured at a peripheral site, such as the thenar eminence, while blood flow is transiently occluded with sphygmomanometer. After reaching a predefined ischaemia time or minimal StO2 threshold, the sphygmomanometer tourniquet is rapidly deflated and blood flow in the muscle is restored. Tissue saturation measurement during VOT can identify early disturbances in tissue metabolism and perfusion. The speed of the decrease in tissue saturation on ischaemia was proposed to reflect the local metabolic rate, while the lowest tissue saturation was proposed to reflect the extent of ischaemia. The speed of tissue saturation recovery on reperfusion in shock patients was proposed as a measure of microvascular capacity to increase blood flow after transient ischaemia. The results of recent studies indicated that the speed of the fall of muscle saturation during VOT is reduced in septic shock, while a decreased speed of saturation recovery on reperfusion is related to disturbed microcirculation, for example in hypovolemic shock. An understanding of anaesthetics and of the influence of cardiac surgical procedures on tissue saturation profile during VOT is essential for the future use of this tool for the assessment of the condition of patients during CPB cardiac surgery.
- Conditions
- NIR Spectroscopy
- Being tested
- NIRS during VOT, General anaesthesia with propofol use, General anaesthesia with sevoflurane use
- Keywords
- Cardiopulmonary Bypass, Anoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS during VOTProcedure or surgery
Near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints:
- 30 minutes after anaesthesia induction,
- directly after the sternotomy,
- during CPB - 20 minutes after aortic cross-clamping ,
- 40 minutes after aortic cross-clamping,
- 20 minutes after the release of the aortic cross-clamp,
- 45 minutes after weaning of CPB.
General anaesthesia with propofol useProcedure or surgery
Also called Propofol Total Intravenous Anesthesia (TIVA)
Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre.
Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure.
Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg.
Maintenance of anaesthesia in 'Propofol' group will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h.
Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60.
General anaesthesia with sevoflurane useProcedure or surgery
Also called Sevoflurane anaesthesia
Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre.
Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure.
Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg.
Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | General anaesthesia with Propofol use. Maintenance of anaesthesia in group P will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h.
Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60.
Intervention: NIRS during VOT on several timepoints. Receives: Procedure: NIRS during VOT; Procedure: General anaesthesia with propofol use |
| Sevoflurane | Experimental | General anaesthesia with sevoflurane use. Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60.
Intervention: NIRS during VOT on several timepoints. Receives: Procedure: NIRS during VOT; Procedure: General anaesthesia with sevoflurane use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in thenar muscle saturation
Thenar muscle tissue saturation was continuously monitored using an INVOS NIRS monitor (INVOS-YM 5100C Cerebral Somatic Oximeter, Covidien, Mansfield, USA).
Thenar muscle saturation was measured during VOT 30 minutes after anaesthesia induction, which will be regarded baseline value.
At five another timepoints VOT was performed and changes in thenar muscle saturation were measured:
- directly after the sternotomy,
- during CPB - 20 minutes after aortic cross-clamping,
- 40 minutes after aortic cross-clamping,
- 20 minutes after the release of the aortic cross-clamp,
- 45 minutes after weaning of CPB.
Measured: During VOT performed at 6 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionAug 2014
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 NIR SpectroscopyStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej M. Kowalik, Medical University of Gdansk
- Investigators
- Alexandra Biedrzycka, M.D., Ph.D., Principal investigator, Medical University of Gdańsk, Department of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593448
- Sponsor's protocol ID
- NKBN/34/2012
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Biedrzycka A, Kowalik M, Pawlaczyk R, Jagielak D, Swietlik D, Szymanowicz W, Lango R. Aortic cross-clamping phase of cardiopulmonary bypass is related to decreased microvascular reactivity after short-term ischaemia of the thenar muscle both under intravenous and volatile anaesthesia: a randomized trial. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):770-778. doi: 10.1093/icvts/ivw232. Epub 2016 Jul 8.
PubMed 27401083
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cardiopulmonary Bypass and Sevoflurane or Propofol Anesthesia on Tissue Oxygen Saturation of Thenar Muscle in Adults.
- ClinicalTrials.gov ID
- NCT02593448
- Acronym / sponsor ID
- NKBN/34/2012
- Conditions
- NIR Spectroscopy
- Keywords
- Cardiopulmonary Bypass, Anoxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Nov 2015 (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 the present study is to assess, by near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on tissue saturation in thenar muscle.
The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue saturation.
It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at the following time points: 30 minutes after anaesthesia induction, directly after sternotomy, 20 and 40 minutes after aortic cross-clamping, 20 minutes after aortic cross-clamp removal, and 45 minutes after weaning of cardiopulmonary bypass (CPB).
Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's test.
Detailed description
Near-infrared spectroscopy (NIRS) is a modern technique for cardiac surgical patient monitoring. The NIRS method is based on Lambert-Beer's law, which defines the relationship between the concentration of a substance and reduction of the intensity of electro-magnetic radiation. This reduction results from photon absorption by chromatophores, including haemoglobin, myoglobin and cytochrome P1. Absorption at the given wave-length depends on the degree of chromatophore oxygenation, and hence allows for its assessment. NIRS is currently commonly used for the assessment of brain oximetry in thoracic aorta surgery and, increasingly often, in open-heart surgery. Algorithms for sustaining adequate brain saturation were reported to decrease the incidence of neurological complications following cardiac surgery. In recent years, NIRS was proposed as a tool for the assessment of muscle saturation under short-term ischaemia and reperfusion, referred to as the vascular occlusion test (VOT). VOT is a provocative test in which tissue saturation (StO2) is measured at a peripheral site, such as the thenar eminence, while blood flow is transiently occluded with sphygmomanometer. After reaching a predefined ischaemia time or minimal StO2 threshold, the sphygmomanometer tourniquet is rapidly deflated and blood flow in the muscle is restored. Tissue saturation measurement during VOT can identify early disturbances in tissue metabolism and perfusion. The speed of the decrease in tissue saturation on ischaemia was proposed to reflect the local metabolic rate, while the lowest tissue saturation was proposed to reflect the extent of ischaemia. The speed of tissue saturation recovery on reperfusion in shock patients was proposed as a measure of microvascular capacity to increase blood flow after transient ischaemia. The results of recent studies indicated that the speed of the fall of muscle saturation during VOT is reduced in septic shock, while a decreased speed of saturation recovery on reperfusion is related to disturbed microcirculation, for example in hypovolemic shock. An understanding of anaesthetics and of the influence of cardiac surgical procedures on tissue saturation profile during VOT is essential for the future use of this tool for the assessment of the condition of patients during CPB cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Procedure: NIRS during VOT, Procedure: General anaesthesia with propofol useGeneral anaesthesia with Propofol use. Maintenance of anaesthesia in group P will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h. Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60. Intervention: NIRS during VOT on several timepoints. |
| Sevoflurane | Experimental | Procedure: NIRS during VOT, Procedure: General anaesthesia with sevoflurane useGeneral anaesthesia with sevoflurane use. Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60. Intervention: NIRS during VOT on several timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult
- scheduled for elective, open-heart cardiac surgical operation with use of cardiopulmonary bypass.
- signed written consent
Key exclusion criteria (5 listed)
- surgeon's intention to use the radial artery for arterial bypass
- symptoms of peripheral atherosclerosis
- paresis of a limb
- autoimmune disease
- other factors that could potentially affect blood flow in the upper extremities
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 |
|---|---|---|
| NIRS during VOTNear infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints: 1. 30 minutes after anaesthesia induction, 2. directly after the sternotomy, 3. during CPB - 20 minutes after aortic cross-clamping , 4. 40 minutes after aortic cross-clamping, 5. 20 minutes after the release of the aortic cross-clamp, 6. 45 minutes after weaning of CPB. | Procedure or surgery | Propofol, Sevoflurane |
| General anaesthesia with propofol useAlso: Propofol Total Intravenous Anesthesia (TIVA)Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre. Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure. Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg. Maintenance of anaesthesia in 'Propofol' group will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h. Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60. | Procedure or surgery | Propofol |
| General anaesthesia with sevoflurane useAlso: Sevoflurane anaesthesiaPremedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre. Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure. Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg. Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60. | Procedure or surgery | Sevoflurane |
Primary outcome
Changes in thenar muscle saturation
Time frame: During VOT performed at 6 timepoints
Thenar muscle tissue saturation was continuously monitored using an INVOS NIRS monitor (INVOS-YM 5100C Cerebral Somatic Oximeter, Covidien, Mansfield, USA). Thenar muscle saturation was measured during VOT 30 minutes after anaesthesia induction, which will be regarded baseline value. At five another timepoints VOT was performed and changes in thenar muscle saturation were measured: 1. directly after the sternotomy, 2. during CPB - 20 minutes after aortic cross-clamping, 3. 40 minutes after aortic cross-clamping, 4. 20 minutes after the release of the aortic cross-clamp, 5. 45 minutes after weaning of CPB.
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 2 Nov 2015.
- Derived from this study: PubMed 27401083Biedrzycka A, Kowalik M, Pawlaczyk R, Jagielak D, Swietlik D, Szymanowicz W, Lango R. Aortic cross-clamping phase of cardiopulmonary bypass is related to decreased microvascular reactivity after short-term ischaemia of the thenar muscle both under intravenous and volatile anaesthesia: a randomized trial. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):770-778. doi: 10.1093/icvts/ivw232. Epub 2016 Jul 8.
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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.
Alexandra Biedrzycka, M.D., Ph.D. principal investigator
Medical University of Gdańsk, Department of Cardiac Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NIRS during VOT, General anaesthesia with propofol use and General anaesthesia with sevoflurane use in people with NIR Spectroscopy, run by Medical University of Gdansk at 1 site in Poland.
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 5 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 2 Nov 2015. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in thenar muscle saturation (time frame: During VOT performed at 6 timepoints). 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 NCT02593448, 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 2 Nov 2015.