A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Phase: NA
Conditions: Anesthesia
Sponsor: DMF Medical Incorporated

 
 
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Full Protocol Title: A NEW AND INNOVATIVE METHOD FOR CO2 REMOVAL IN 
ANESTHESIA CIRCUITS: REPLACING CHEMICAL GRANULATE 
ABSORBERS  
 
 
Protocol Version: 14 
 
Trial Registration Number: NCT03014336 
 
Funder: Unfunded 
 
Sponsor: DMF Medical Incorporated 
 
Roles and Responsibilities: 
Principal Investigator: Dr. Orlando Hung, MD, FRCPC 
Site Investigator, Dartmouth General Hospital: Dr. Tracy Kok 
Research Coordinator: Vera Lloyd 
Sub-Investigator(s): As per Appendix B 
 
 
 
 
 
 
 
 
 
 
 
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TABLE OF CONTENTS 
TABLE OF CONTENTS ................................................................................................................ 2 
SYNOPSIS .................................................................................................................................... 4 
 
STUDY OBJECTIVES AND OUTCOMES ............................................................................. 6 
 Objectives ............................................................................................................................ 6 
 Primary Objectives .............................................................................................................. 6 
Description of the Device: memsorb ........................................................................................... 10 
 Rationale ........................................................................................................................... 10 
 Supporting Data ................................................................................................................. 12 
Previous Work To Date ............................................................................................................... 12 
 
STUDY DESIGN .................................................................................................................. 14 
 
SELECTION AND ENROLLMENT OF PARTICIPANTS ..................................................... 14 
 Study Setting and Sample Size ......................................................................................... 14 
 Eligibility Criteria ................................................................................................................ 15 
 Study Enrollment Procedures ............................................................................................ 15 
 Randomization Procedures ............................................................................................... 16 
 Blinding .............................................................................................................................. 16 
 
STUDY INTERVENTIONS .................................................................................................. 16 
 Interventions, Administration and Duration ........................................................................ 16 
 Handling of Study Interventions ......................................................................................... 16 
 Concomitant Interventions ................................................................................................. 16 
 Adherence Assessment ..................................................................................................... 17 
 
CLINICAL AND LABORATORY EVALUATIONS ................................................................ 18 
 Schedule of Evaluations .................................................................................................... 18 
 Timing of Evaluations ........................................................................................................ 18 
 Definitions .......................................................................................................................... 19 
 
ADVERSE EVENTS ............................................................................................................ 19 
 
CRITERIA FOR DISCONTINUATION ................................................................................. 19 
 Study Withdrawal Procedures ........................................................................................... 19 
 Termination or Suspension of the Study ........................................................................... 19 
 
STATISTICAL CONSIDERATIONS ..................................................................................... 20 
 General Design Issues ...................................................................................................... 20 
 Outcomes .......................................................................................................................... 20 
 Sample Size and Accrual .................................................................................................. 21 
 Data Analyses ................................................................................................................... 21 
 
DATA COLLECTION AND QUALITY ASSURANCE ........................................................... 22 
 Data Collection .................................................................................................................. 22 
 Study Records ................................................................................................................... 22 
 Quality Assurance ............................................................................................................. 22 
 
SAFETY MONITORING ................................................................................................... 22 
 
ETHICAL CONSIDERATIONS RELATING TO THE TRIAL ............................................ 22 
 Research Ethics Board (REB) Review and Informed Consent .......................................... 23 
1. 
1.1. 
1.2. 
1.3. 
1.4. 
2. 
3. 
3.1. 
3.2. 
3.3. 
3.4. 
3.5. 
4. 
4.1. 
4.2. 
4.3. 
4.4. 
5. 
5.1. 
5.2. 
5.3. 
6. 
7. 
7.1. 
7.2. 
8. 
8.1. 
8.2. 
8.3. 
8.4. 
9. 
9.1. 
9.2. 
9.3. 
10. 
11. 
11.1. 
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 Participant Confidentiality .................................................................................................. 23 
 Study Modification/Discontinuation .................................................................................... 23 
 
PUBLICATION OF RESEARCH FINDINGS .................................................................... 23 
 
REFERENCES ................................................................................................................. 24 
 
APPENDICES .................................................................................................................. 25 
 Appendix A: L-SOP-14001 Memsorb Device Installation and Basic Use Training 
Procedure and Attachment 1 ...................................................................................................... 25 
 Appendix B: Feeder List to Delegation and Signature Log ................................................ 25 
 
11.2. 
11.3. 
12. 
13. 
14. 
14.1. 
14.2. 
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scotia 
ealth 

 
 
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SYNOPSIS  
 
a. Study Title 
A NEW AND INNOVATIVE METHOD FOR CO2 REMOVAL IN ANESTHESIA 
CIRCUITS: REPLACING CHEMICAL GRANULATE ABSORBERS 
 
b. Objectives 
To demonstrate that memsorb can maintain safe levels of CO2, measured at the 
end of expiration throughout the duration of anesthesia in patients of varying 
weight and ventilation requirements during different surgical procedures. 
 
c. Design and Outcomes 
This is an investigational study comparing two methods of CO2 removal in 
anesthesia – the first being traditional chemical granulate, and the second being 
memsorb™ a CO2 filtration system that relies on medical membranes and flush 
gas to remove CO2 from the patient rebreathing system. Participants will be 
assigned to groups based on their willingness to participate and group capacity at 
that time. Patients will be consented to the device intervention or control group. 
The trial will evaluate the equivalence of the two CO2 removal methods. Standard 
electronic data collection will occur during the induction and maintenance of 
general anesthesia throughout the procedure. Data will be pulled from the 
anesthesia database. 
 
d. Interventions and Duration 
Intervention participants will consent to the use of the memsorb filter for the 
length of time required to perform their elective surgery procedure. 
 
e. Sample Size and Population 
Approximately three hundred participants from the general population scheduled 
to undergo elective surgery will be recruited.  
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Principal Investigator Approval Statement 
 
I have read this protocol and agree to conduct this clinical trial as outlined herein. I will ensure 
that all sub-investigators and other study staff members understand all aspects of this protocol. I 
will adhere to the Declaration of Helsinki and its amendments, the International Conference on 
Harmonization (ICH) principles of Good Clinical Practice (GCP; including archiving of essential 
study documents) and all applicable regulations and guidelines of the country in which the study 
is conducted. 
 
Principal Investigator: 
 
Printed Name: Dr. Orlando Hung 
 
 
 
 
 
 
 
 
Signature:  
 
 
 
 
 
 
 
 
 
 
 
Date:   
 
 
 
 
 
 
 
 
 
 
 
 
A NEW AND INNOVATIVE METHOD FOR CO2 REMOVAL IN ANESTHESIA CIRCUITS: 
REPLACING CHEMICAL GRANULATE ABSORBERS 
 
 
Protocol Revised: 2021-12-20 
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 STUDY OBJECTIVES AND OUTCOMES 
The purpose of the proposed research trial is to validate earlier bench, animal results and 
human results in a larger patient population. Therefore, the study is designed to directly 
compare the memsorb filter device with currently used chemical granulate absorbers used at 
Nova Scotia Health in 300 elective surgeries. The primary objective of this analysis will 
demonstrate that memsorb can maintain safe levels of CO2, measured at the end of expiration 
throughout the duration of anesthesia in patients of varying weight and ventilation requirements 
during different surgical procedures.  
 Objectives 
 Primary Objectives 
The primary objective of this trial is to compare the performance of memsorb™ relative to the 
chemical granulate absorbers currently used at Nova Scotia Health and most other hospitals in 
Canada. memsorb™ removes CO2 from the patient circuit using hollow fiber membrane filtration. 
Exhaled CO2 diffuses through the hollow fibre membrane due to a partial pressure gradient. The 
CO2 is then removed from memsorb™ via a flush gas which is comprised of medical oxygen and 
air.  
Our primary outcome measure will be a simple YES (1) or NO (0), stating if the expiratory (EtCO2) 
levels stayed in the clinically desired range of (4.1-5.6) % CO2 with both manual and electronic 
flush gas blenders. In addition, both groups will be compared using an ANCOVA, where 
secondary measures will be used as variables for the ANCOVA to increase power.  
EtCO2 is an accepted surrogate measure to assess the concentration of CO2 in the blood 
(paCO2) and therefore the pH. This is common practice for anesthesiologists worldwide, 
avoiding the need for repeated invasive blood gas analysis. The EtCO2 is therefore the most 
important patient ventilation parameter besides the oxygen saturation of hemoglobin SaO2. See 
“Data Analyses” (Section 9 below) for a statistical summary. 
 
Secondary measures that will have no direct clinical impact will also be collected. These 
measures include length of surgery, method of ventilation, an export of the content of the ‘notes 
field’ from Innovian, inhaled and exhaled fraction of anesthetic agent, vapour use (where 
available), fraction of inspired and expired oxygen (FiO2, FeO2), fraction of inspired Carbon 
Dioxide (FiCO2), arterial blood gas analysis results (pH and paCO2 where available), patient 
temperature, relaxation status (train of four) during surgery (where available), ventilation 
frequency, minute volume (MV), tidal volume (TV), ventilation pressures (i.e. peak, mean, peep 
and plat pressure), fresh gas flow, and compliance (ml Tidal Volume/ cmH2O ventilation 
pressure), along with physiological parameters such as heart rate, blood pressure (where 
available), SaO2, SpO2, and biometric data such as patient weight and height, age, medication, 
history of lung disease will provide metrics to demonstrate other ventilator parameters remain in 
the target range of (4.1-5.6) % CO2, and will be collected through the anesthesia and nursing 
databases. Additionally, relative humidity and temperature of the circuit will be measured 
throughout surgery via a dedicated port in the inhalation and exhalation leg of the anesthesia re-
breathing circuit. Relative humidity and temperature will also be measured in a defined volume 
~[50mL] of the exhaled gas coming from the participant on the patient side of the HME filter 
1. 
1.1. 
1.2. 
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using a sterile sampling line. In a sample of patients, a measurement of the pH at various points 
within the re-breathing circuit, using litmus paper, will be taken following the extubation of the 
participant.  
 
Secondary Objective 
The secondary objective of this study is to examine the use of the memsorb filter device by 
anesthesiologists whose standard-of-care includes the use of low fresh gas flows. 
 
Tertiary Objective 
This study will also evaluate the useful life of up to 50 chemical CO2 absorbers by tracking the 
number of hours they are used before being discarded. This portion of the study will not require 
any participant data collection.  
 
New objective 
Two different methods of flush gas supply will be compared – the standard manual flush gas 
blender that has been used to date [Manufacturer: Precision Medical HC License 71950] and 
electronic flush gas blender [HC ITA# to be determined]. 
The electronic flush gas blender will be evaluated to demonstrate it can electronically adjust the 
flush gas composition supplied to memsorb™ to match the composition of the machine-side gas 
set by the anesthesiologist (Target FiO2). This will be evaluated using standard ventilation 
parameters collected by the Innovian® system (e.g., machine-set target concentration of FiO2, 
and patient FiO2).  
 
 
BACKGROUND 
In recent years anesthesia and surgery have been shown to incite a syndrome known as Post 
Operative Cognitive Decline (POCD) (Bryson & Wyand 2006). The syndrome is particularly 
common in elderly patients and patients undergoing procedures involving the cardiopulmonary 
bypass (CPB) (Silverstein et al. 2007).  
Half of all the surgical procedures performed in 1999 were performed on elderly patients 65 
years or older, reflecting 12% of the current population. This number is increasing (Etzioni et al. 
2003). Patients with POCD often exhibit impaired cognitive functioning in their thinking, 
perception and memory, and they have a more than fivefold increase in their mortality rate for 
the 12 months after surgery and anesthesia (Monk et al. 2005; Lewis 2007). The type of surgery 
performed and the age of the patient both affect the risk of developing POCD, with very young 
and elderly patients being at particularly high risk (Rasmussen 2006). The average incidence 
rate of POCD ranges up to 25% (Bryson & Wyand 2006) where the highest incidence is 
reported for cardiac surgery at up to 70% (Silverstein et al. 2007).  
Enough concern has been raised in relevant medical circles to warrant the attention of the 
Anesthesia Patient Safety Foundation (APSF) of America (since 2004). More recently a New 
York Times article highlighted the FDA’s Smart Tots program in collaboration with the 
International Anesthesia Research Society (IARS) which explores the side effects of vapor 
~~vascotia health 

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inhale                          
exhale
ABSORBER
Figure 2: Schematic of a closed circuit with absorber
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its toxicity to the kidney and brain cells are described best in literature. Brain cells in a culture 
die after being exposed to Compound A (Konat et al. 2003).  
These findings have resulted in the requirement for a minimum fresh gas flow into the anesthetic 
circuit, replacing up to two thirds of the volume in the circuit each minute to dilute these toxic 
compounds. While a CO2 absorber makes closed circuit per se possible, current absorbers stay 
in the way of safely achieving a fully closed circuit. Reducing the fresh gas flow linearly reduces 
the amount of vapour used (Ekbom et al. 2007). For example, reducing the fresh gas flow from 
3l/min to 1.5l/min reduces the required anesthetic drug use from (0.16±0.05)ml/min to 
(0.07±0.03)ml/min (Doolke 2001). 
Current absorbers also form corrosive (alkalotic) dust that may accumulate in the ventilation 
circuit (see Figure 3). Even the best filters available (combined bacterial/viral filters separating 
the patient from the anesthetic circuit) allow dust particles smaller than 20 nm to get pass the 
filter and enter the patient's lungs. Larger dust particles 
can accumulate on the filter’s surface, come into contact 
with water sitting on the filter and therefore potentially pass 
the filter in solution. If this dust or solution is allowed to 
contact tissue for any length of time, a chemical burn will 
occur and can potentially lead to life threatening conditions 
such as laryngospasm, bronchospasm or pneumonia 
(Sodasorb 1993). The dust also accumulates in the circuit 
and can lead to fatal mechanical failures like blocked 
valves (Kummar et al. 2009). 
Figure 3: Alkalotic dust in the cap of a 
newly unpacked absorber 
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Description of the Device: memsorb 
memsorb is a patented innovative carbon dioxide (CO2) filter that aims to remove CO2 from 
anesthetic circuits as effectively as current chemical absorbers. memsorb is a class II device 
approved for sale by Health Canada (license no. 104717). This device is unique in that aspect, 
instead of chemically binding the CO2 as state of the art absorbers, it separates the CO2 from 
the residual gas components including the anesthetic drug within the circuit without any 
chemical granulate that could cause degradation of vapors. Existing anesthetic machines use 
chemical granulate loosely packed in a container to absorb exhaled CO2 (see Figure 4). In the 
process, not only the CO2, but also the anesthetic drug reacts with the chemical granulate and 
creates the known compounds A-E. It also creates other toxic substances such as carbon 
monoxide, formaldehyde, and methane to name just a few.  
 
Our innovative alternative to the classic absorber, memsorb, uses an alternate process to 
remove the CO2. Instead of absorbing (chemically binding) the CO2, memsorb separates the 
CO2 from the gas mixture using membrane technology and removes the CO2 via a flush gas as 
evaluated previously.  
 
The flush gas is comprised of medical 
oxygen and air at a concentration equal to 
the machine-side target fraction of O2. To 
date, the flush gas has been blended and 
administered via a manual blender 
(Precision Medical, HC License #71950). An 
electronic blender (HC ITA# 335727) will be 
evaluated to automatically adjust the flush 
gas to match the machine-side target 
fraction of FiO2. 
 
The device uses membrane technology, 
which has been proven effective and safe in 
other medical applications like dialysis and 
blood oxygenation for decades.  
The test device is capable of being used with any anesthesia machine/ system in the world 
today, as it is similar in shape, size, and interface to existing absorber cartridges, provides the 
same performance and therefore does not require additional training or change in clinical 
practice. (Note: installation is identical to current absorber cartridges as explained in L-SOP-
14001 provided in Appendix A) 
 Rationale 
CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers 
pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic 
Figure 4: Draeger anesthesia machine with 
state-of-the-art chemical absorber 
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1.3. 

 
 
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drugs, producing organ toxic substances. The proposed CO2 filter, memsorb, provides a 
solution to the problem of organ-toxin production in anesthetic circuits. 
memsorb can be easily integrated into any anesthesia circuit and can effectively remove CO2 
without reacting with anesthetic drugs, thus eliminating organ-toxic by-products. 
memsorb uses advanced membrane technology to separate gas flows within the circuit, 
separating the expensive anesthetic vapors from the CO2 (the main by-product of metabolism). 
Anesthetic vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted 
to the atmosphere, rather than being absorbed through a chemical reaction. 
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 Supporting Data 
 
Previous Work To Date 
The performance of memsorb has been studied in large animal (pig) studies led by Dr. Michael 
Schmidt using standard human patient equipment and pilot study in humans led by Dr. Orlando 
Hung.  
The human study in 2014 compared memsorb to the market leader in CO2 absorption (Draeger) 
in a human clinical trial with 20 subjects. This pilot-study showed that memsorb is as effective 
and safe as the market leader. There were no adverse events reported. 
 
The pig studies have demonstrated that this device is highly effective in maintaining expiratory 
CO2 levels necessary to maintain a stable pH in the animal. The pig model organism provides 
highly similar anatomical, physiological, and genetic landscapes to those observed in humans. 
In addition, chemical granulate CO2 absorbers that are the current standard in human 
anesthesia perform in an identical fashion when used in pigs. 
As a pre-clinical model, a pig model was chosen since their pulmonary physiology allows for the 
use of unmodified, full size, state-of-the-art equipment used in humans. 
After ethics approval by the local animal care committee, pigs received a mask induction using 
Sevoflurane. Once asleep, they were intubated and ventilated by an anesthesia machine 
(Tangens 2C, EKU, Germany). 
While the anesthesia machine supplies on-board state-of-the-art monitoring of the ventilation 
parameters, a patient monitor (Datex Ohmeda, Sweden) was connected to collect additional 
ventilation data. Figure 5 shows the pressure-volume relationship (compliance) and the flow-
volume relationship of the system. Furthermore, the peak (Ppeak) plateau (Pplat) and PEEP 
pressures as well as the inspired (TVinsp) and expired (TVexp) volumes are displayed. 
 
 
~vascotia health 
1.4. 

 
 
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Figure 5: Sample spirometry data from Datex Ohmeda patient monitor. (left) flow-volume relationship of the system, 
(right) compliance (pressure-volume relationship). Furthermore, the peak (Ppeak) plateau (Pplat) and PEEP pressures as 
well as the inspired (TVinsp) and expired (TVexp) volumes are displayed. 
When replacing the traditional, chemical granulate based absorber with the test device 
memsorb, compliance1, flows and pressures were observed using the patient monitor data 
(Figure 5). None of the parameters on the patient monitor regarding compliance, flows and 
pressures changed when switching to memsorb. 
End tidal CO2 (EtCO2) is a clinically accepted surrogate measure for the CO2 concentration 
(paCO2) in the patient’s blood. Keeping the paCO2 in a range of (40±4) mmHg is important to 
keep the directly dependent pH2 in the patient’s blood in a healthy range. The gradient between 
the paCO2 and the EtCO2 is typically in the range of (1-5) mmHg (Corbo et al. 2005) resulting in 
a safe range for the EtCO2 of (31-43) mmHg equivalent to (4.1-5.6) % at normobaric pressure3. 
All standard parameters of ventilation were applied for testing memsorb (see Table 1).  
 
Table 1: Ventilation parameters used 
Frequency  
[breath × min-1] 
Tidal Volume 
[ml × breath-1] 
Minute Volume 
[liter × min-1] 
12 
600 
7.2 
 
There were no obvious changes observed in flow patterns, circuit compliance, pressures or 
volumes delivered under usage of memsorb. There was no difference in operating memsorb in 
comparison to the state-of-the-art absorber from the anesthesiologist’s perspective.  
 
 
1 Flow per pressure unit 
2 
 
3 1 atm = 760 mmHg. (40/760) = 5.3% 
~vascotia health 
( 
[HC0 3] ) 
( 
[HC0 3] ) 
pH= 
6.1 + log10 
----
pH= 
6.1 + log10 
0.03 x PaCO 2 
0.03 x PaCO 2 

 
 
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The primary outcome measure EtCO2 was continuously in the target range of (4.1-5.6) % CO2 
using memsorb (see Table 2) and kept stable. 
 
Table 2: In vivo test data with different fresh gas mixtures 
and flows resulting in EtCO2 values reliably in the 
physiologically desirable range of (4.1-5.6) % CO2. 
Fresh Gas  
[litre × min-1] 
Fresh Gas 
[%O2, %Air] 
EtCO2 [%] 
MEAN    ±STDEV 
2 
100, 0 
5.32 
0.15 
4 
100, 0 
5.20 
0.05 
2 
50, 50 
5.28 
0.15 
4 
50, 50 
5.32 
0.04 
 
All data is unpublished research data from the Michael Schmidt Research Group. Animal Care 
approval and Health Canada drug exemption were obtained before conducting this study. 
Based on these results, we expect that memsorb will perform safely and effectively in human 
subjects. 
 STUDY DESIGN 
This is an investigational study comparing EtCO2 levels in patients using either a new CO2 filter 
memsorb, or the standard chemical granulate absorber. Flush gas through memsorb™ will be 
provided via a manual Health Canada–approved air-oxygen blender, or an electronic blender 
under Health Canada Investigational Testing Authorization. Participants will be assigned to 
groups based on their willingness to participate and study capacity. Patients who do not consent 
to using the new device may be given the option to participate as control patients. 
The current trial will evaluate the equivalence of two CO2 removal methods. Standard electronic 
data collection will occur during the induction and maintenance of general anesthesia 
throughout the procedure. Data will be pulled from the anesthesia and nursing databases 
(Draeger Innovian and McKesson Horizon Surgical Manager respectively.  
 
 SELECTION AND ENROLLMENT OF PARTICIPANTS 
 Study Setting and Sample Size 
Approximately three hundred patients undergoing general anesthesia for an elective surgical 
procedure will be recruited from either the Queen Elizabeth II Health Sciences Center (QEII 
HSC), Halifax, Nova Scotia or the Dartmouth General Hospital (DGH), Dartmouth, Nova Scotia. 
See Standard Operating Procedure for Obtaining informed consent and enrolment in memsorb 
study trial and attached recruitment flow chart. 
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3. 
3.1. 

 
 
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Participants will receive the same treatment / anesthesia per the standard of care at Nova Scotia 
Health. There is variation from the standard of care in the interventional group by the use of a 
Health Canada–approved device (memsorb). The anesthesia procedure will be performed 
according to the standards of the attending anesthesiologist. If a participant is willing to be 
included in the interventional group, the standard chemical granulate absorber will be replaced 
with a memsorb filter. If a participant is not interested to be included in the interventional group, 
the regular chemical granulate absorber will be used for the procedure. 
Due to the technical nature of this trial and our goal of maintaining the highest standard of safety 
for the patient, the anesthesiologist will not be blinded to the absorber/filter type (chemical 
absorber or memsorb filter) being used during surgery. Additionally, since we are using objective 
measures, i.e., EtCO2, the anesthesiologist will not need to be blinded to the group.  
 Eligibility Criteria 
 
Inclusion Criteria 
• 
American Society of Anesthesiologists Physical Status Class I, II, III 
(low-medium risk patient) 
• 
English-speaking patients 
 
Exclusion Criteria 
• 
Self-reported as pregnant 
• 
American Society of Anesthesiologists Physical Status Class IV (high 
risk patient) 
• 
Patients scheduled for emergency surgery 
• 
Documented respiratory disease, such as COPD and severe asthma 
• 
Documented elevated pressure in the brain (intra cranial pressure, ICP) 
 Study Enrollment Procedures 
 
Methods for identifying and recruiting candidates for the trial 
Following the Informed consent and enrolment procedure for memsorb clinical study and 
attached recruitment flow chart, approximately three hundred participants,110 in the control 
group and 190 in the intervention group, will be recruited on the day of surgery. During 
registration with the front desk, the patients will be asked by staff if they are interested in being 
approached for a research study, and if they are willing to sign the “Access to Personal Health 
Information” form for screening purposes. Patients will be identified by a member of the 
research team using the screening parameters and will be offered the opportunity to participate 
in this research study and upon expression of interest to participate, will be walked through the 
informed consent process. The participants will be informed that the final decision about 
enrollment will be based on the anesthesiologists’ assessment for fit during the pre-op 
assessment. The anesthesiologist and research coordinator will be on hand to answer any 
questions the patient may have. Two hundred patients will be recruited for the memsorb group, 
using the “Informed Consent Form, Clinical Trial – Device”, and one hundred patients will be 
recruited for the control group, using the “Informed Consent Form, Clinical Trial – Control”. 
3.2. 
3.2.1. 
3.2.2. 
3.3. 
3.3.1. 
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During surgery, any adverse events during the use of memsorb will be reported in the Patient 
Safety Reporting System as mandated by NS HEALTH, the REB, and Health Canada. 
 
 
Consent procedures 
Refers to the Informed consent and enrolment procedure for memsorb clinical study.  
 Randomization Procedures 
Not Applicable 
 
 
Sequence Generation 
Not Applicable 
 
 
Concealment Mechanism 
Not Applicable 
 Blinding 
Not Applicable 
 
STUDY INTERVENTIONS 
 Interventions, Administration and Duration 
Intervention participants will be screened for a study operating room in which their surgery will 
be performed, whether the anesthesiologist scheduled for that room will be trained on the use of 
the memsorb filter and delegated to this study, and for a procedure expected to be performed 
under general anesthesia. Enrolment will be conducted per the memsorb Device Installation and 
Basic Use Training Procedure. Intervention participants who consent will use the memsorb filter 
for the length of time required to have their elective surgery procedure performed. The 
anesthesia procedure will be performed according to the standards of the attending 
anesthesiologist. 
 
 Handling of Study Interventions 
Patients in the interventional group will be recruited from Nova Scotia Health sites noted in 
section 4.1 undergoing general anesthesia for an elective surgical procedure and will receive 
the memsorb device in lieu of the standard Draegersorb device. 
 Concomitant Interventions 
Not Applicable. 
 
 
Required Interventions 
Not Applicable. 
 
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3.3.2. 
3.4. 
3.4.1. 
3.4.2. 
3.5. 
3.6. 
3.7. 
3.8. 
3.8.1. 

 
 
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Prohibited Interventions 
Not Applicable. 
 
 
Precautionary Interventions 
Not Applicable. 
 
 Adherence Assessment 
 Not applicable. 
3.8.2. 
3.8.3. 
3.9. 
3.10. 
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 CLINICAL AND LABORATORY EVALUATIONS 
 Schedule of Evaluations 
Not applicable as the length of this study for participants is for as long as the general anesthesia 
procedure lasts. The total length of participation will depend on the length of surgery. There are 
no pre or post clinical evaluations. 
 Timing of Evaluations 
Not Applicable 
 
 
Pre-Intervention Evaluations 
Not Applicable 
 
 
Screening 
As per the Investigator Information Sheet 
 
 
Baseline Evaluations 
Determine if the potential participant satisfies the eligibility requirements as per the memsorb 
study inclusion / exclusion criteria 
 
 
Intervention Assignment and/or Initiation 
After it is determined that the participant satisfies the memsorb study criteria and after informed 
consent for either the interventional or control group has been obtained an enrollment number is 
assigned. The anesthesiologist performs a final assessment for fitness for the study for 
participants consented for the interventional group. Ability to assign patients to either group, 
together with interest by the patient to participate generates a non-biased assignment of 
patients to either group, which could be considered random. 
 
 
On-Intervention Evaluations 
Since the anesthesia procedure will be performed according to the standards of the attending 
anesthesiologist no additional evaluations outside the standard of care will be performed. 
 
 
Intervention Discontinuation Evaluations 
If during surgery, the memsorb filter fails, the anesthesiologist will swap the experimental device 
for the standard chemical-based CO2 absorber, or, in the event there is not a standard device 
available, the circuit will be opened to vent CO2 out the stack. There will not be any additional 
evaluations outside the standard of care. 
 
Post-intervention Follow-up Evaluation 
No further follow-up will be required as we are only using intra-operative data.  
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4. 
4.1. 
4.2. 
4.2.1. 
4.2.1.1. 
4.2.1.2. 
4.2.1.3. 
4.2.2. 
4.2.3. 
4.2.4. 

 
 
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Final Evaluations 
Not Applicable 
 
 
Post-Study Requirements 
Not Applicable 
 
 
Pregnancy (Optional) 
Not Applicable 
 
 Definitions 
 
Informed Consent 
A participant’s agreement to participation in a clinical study after being properly advised of the 
relevant medical facts and the risks involved.  
 
Control Participant 
Surgery is conducted using the standard CO2 absorber, and only data is collected. There is no 
difference in how the anesthesiologist will manage general anesthesia during surgery. There will 
not be any additional treatments.  
 
 ADVERSE EVENTS 
During surgery, any adverse events during the use of memsorb will be reported in the Patient 
Safety Reporting System as mandated by NS HEALTH, the REB and Health Canada. 
Adverse advents will be reviewed and if determined to be related to the memsorb filter, be 
reported to the REB per their requirements. All serious unexpected adverse reactions will be 
reported to Health Canada per Health Canada’s Mandatory Problem Reporting guidelines (from 
Health Canada’s Medical Device Regulations) and the sponsor. 
 
 CRITERIA FOR DISCONTINUATION 
 Study Withdrawal Procedures 
Participants may withdraw at any time and their information will not be used in the data analysis. 
 Termination or Suspension of the Study 
The study sponsor, the Nova Scotia Health Research Ethics Board, Health Canada, and the 
principal investigator have the right to stop patient recruitment or cancel the study at any time.  
4.2.5. 
4.2.6. 
4.2.7. 
4.3. 
4.3.1. 
4.3.2. 
5. 
6. 
6.1. 
6.2. 
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 STATISTICAL CONSIDERATIONS 
 General Design Issues 
This study aims to compare the ability of current chemical CO2 absorbers and memsorb to 
maintain safe EtCO2 levels in a variety of patients. In order to increase power, additional patient 
and ventilation parameters will be investigated for their fit as co-variables in the main analysis. In 
general, they will also allow the detailed description of the patient population in each group and 
may provide the ability to subdivide the patient populations into homogenous patient populations 
if not given already.  
The memsorb filter device has a feature which supports using fresh gas flows less than 1Lpm. 
Current CO2 absorbers (control) do not recommend fresh gas flows lower than 1 Lpm. Since low 
fresh gas flow equivalence of the two devices cannot be compared, a subset of participant data 
using the memsorb device only, will be collected using anesthesiologists whose standard-of-care 
includes the use low fresh gas flows. 
 
We propose that 300 participants are recruited to the study overall. 
190 intervention participants be recruited: 
• 
130 procedures requiring general anesthesia be performed using the memsorb filter 
device  
• 
60 procedures requiring general anesthesia be performed using the memsorb filter device 
and anesthesiologists whose standard-of-care includes the use of low fresh gas flows.  
o From this cohort, 40 participants will be assigned memsorb™ with the electronic 
flush gas blender  
Metrics from these procedures will be compared to that derived from 110 procedures using the 
current standard of care (controls), which is a chemical granulate based absorber.  
 
 Outcomes 
 
Primary outcome 
The experimental design will include the independent variable of CO2 removal, by comparing the 
traditional chemical granulate absorber device, (control) to the memsorb CO2 membrane filter 
device (interventional) to determine if they are maintaining the CO2 at safe levels.  
Ventilation and patient parameters, potentially influencing the primary outcome, will be collected 
and analyzed for their fit to be used as covariates for the primary outcome analysis in order to 
aim for increased power, sensitivity and potentially the ability to describe homogenous 
subgroups in case the patient population is not normally distributed in regards to key primary or 
secondary parameters. 
 
7. 
7.1. 
7.2. 
7.2.1. 
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Secondary outcomes 
The study will collect data from anesthesiologists’ whose standard-of-care includes the use of 
low fresh gas flows when using the memsorb filter device.  
 
7.2.3 Tertiary outcomes 
This study will track the number of hours each chemical CO2 absorber is in use (from initial 
installation through to discarding), to establish the average lifespan of traditional CO2 absorbers. 
The FGF at which each CO2 absorber is used will also be collected in order to establish an 
exhaustion curve to determine the average lifespan in view of fresh gas flows.  
 
7.2.4 Quaternary outcomes 
This outcome will evaluate the ability of an electronic flush gas blender to provide a flush-gas 
through memsorb™ that matches the concentration of the machine-set target fraction of O2. The 
flush gas should be the same concentration as the machine side gas to limit partial pressure 
differences in O2, which could cause O2 to transfer across the membrane.  
To determine the flush gas concentration is not statistically different from the machine-side gas 
concentration, two measures will be extracted from the Innovian® system; machine-set target 
fraction of O2, and patient side FiO2. A statistically insignificant difference between the two values 
indicates the flush gas concentration was successfully matched to the machine-side 
concentration. The analysis will be performed using standard statistical methodologies. 
 
 Sample Size and Accrual 
Due to a lack of reported effect size data related to this technology, a formal power analysis 
cannot be provided. 200 patients is considered “typical” for a device safety study with HC and 
the FDA. This is a clinical trial for a Class II medical device. In comparison, drug clinical trials at 
the same stage of development (Phase II Clinical Trials) enroll between 100 and 300 
participants. Based on this it was determined that a total of 300 participants would be recruited 
for this clinical trial. A direct comparison of 110 hundred participants in the control group and 
130 participants in the intervention group will be performed. Also, data from approximately 60 
additional participants consented to the intervention group only, will be collected to evaluate 
standard-of-care use of low fresh gas flows.  
 Data Analyses 
The primary variable EtCO2 is given as repeated measures and will therefore be analyzed using 
an ANCOVA. ANCOVA in this case provides the additional benefit over an ANOVA, that 
secondary parameters can be used as covariates in order to potentially increase power and 
sensitivity. Secondary parameters may also be used, to subdivide the group data into more 
homogenous subgroups for representative purposes in addition to the ANCOVA.  
The data from the 50 participants where anesthesiologists’ standard-of-care while using the 
memsorb device includes using low fresh gas flows will help establish and provide supporting 
documentation for an initial range of fresh gas flows suitable for use with the memsorb device. 
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7.2.2. 
7.3. 
7.4. 

 
 
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 DATA COLLECTION AND QUALITY ASSURANCE 
 Data Collection 
 
Innovian and HMS 
Primary and secondary parameters are exported from the Anesthesia Innovian and nursing 
perioperative documentation system (Horizon Surgical Manager). 
 
Manual data collection 
Useful lifespan of chemical CO2 absorbers is recorded manually from study staff (medical 
students) whenever cartridges are replaced in the OR. The fresh gas flow rates at which the 
CO2 absorbers are used will be recorded during each procedure to establish an exhaustion 
curve. No participant data will be collected during this portion of the study. 
 Study Records 
 
Data Management 
The Data export from the Innovian and HMS databases is managed by the quality improvement 
office of the Department of Anesthesia. Data is de-identified by the Research Coordinator and 
only the de-identified data becomes part of the binder accessible by all study staff and is 
provided to the study sponsor. 
 
All data transfers are protected by TLS and is encrypted using 256-bit AES encryption.  
 
Data will be deleted from all storage device of the study group and the sponsor after 25 years 
and all paper records will be destroyed. Only data required by scientific papers and regulatory 
agencies for documentation purposes will be kept beyond that point. 
 
 Quality Assurance 
Not applicable. 
 SAFETY MONITORING 
Anesthesia has been performed with semi-open (without any CO2 absorber) systems for 
decades, safely. This proves that even in the unexpected case of a malfunction of a memsorb 
device, anesthesia can be performed safely without any CO2 absorption in the circuit using a 
higher level of fresh gas flow. This can be achieved by opening up the circuit and continuously 
venting fresh gas. Because of this, there is no additional risk to the patient if the test device, or 
standard chemical granulate absorber, does not perform as expected. A failure of memsorb is 
equivalent to the regular exhaustion of current chemical absorbers and therefore reacting to 
such incident is standard practice. 
 ETHICAL CONSIDERATIONS RELATING TO THE TRIAL 
8. 
8.1. 
8.2. 
8.2.1. 
8.3. 
9. 
10. 
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 Research Ethics Board (REB) Review and Informed Consent 
i. 
There are no direct benefits to participating in this trial, besides enlarging the body of 
knowledge in the field.  
 
ii. 
Informed consent is obtained as per the Standard Operating Procedure for Obtaining 
informed consent and enrolment in memsorb study trial. 
 
iii. 
Study bias is minimized through the assignment of suitable participants. NS HEALTH 
assigns potential participants to a specific OR room, with a specific anesthesiologist. 
The research coordinator responsible for recruitment has no control over this. Eligible 
participants are only determined on the day of, after these assignments have been 
determined. 
 
iv. 
Conflict of interest: The PI does not have any affiliation with the sponsor company, 
DMF Medical Inc. The sponsor and the institution are distinct entities without overlap 
of responsibilities or business concerns. Although Dr. Schmidt is a staff 
anesthesiologist and colleague of Dr Hung, Dr. Schmidt has no influence on this study 
given that he is excluded from participation.  
 Participant Confidentiality 
Data will be collected directly from the Anesthesia management and nursing management 
system. All trial records of participants will be kept strictly confidential and will be maintained 
within NS HEALTHs electronic system. For the purposes of device comparisons there is no 
requirement that any data points retrieved be linked back to a specific patient identifier. For 
auditing purposes, or in the event a memsorb participant wishes to have their data excluded 
from the study, each memsorb data set will de-identified using a unique identifier. A master file 
will be kept by the Principal Investigator only, which links patient name with unique identifier. 
Trial data will be kept for 25 years per NS HEALTH’s requirements. De-identified trial data will 
only be made available to the principal investigator and assigned trial personnel as they are 
identified in this application (CVs appended). Patient participants will not be identified in any 
reports or publications as a result of participation in this trial. Records may be shown to the NS 
HEALTH Research Ethics Board in the case of an audit. 
 Study Modification/Discontinuation 
Participants may withdraw at any time and their information will not be used in the data analysis. 
The study sponsor, the Nova Scotia Health Research Ethics Board, Health Canada, and the 
principal investigator have the right to stop patient recruitment or cancel the study at any time. 
Modifications to this study will be submitted to the NS HEALTH REB as per institutional policy. 
 PUBLICATION OF RESEARCH FINDINGS 
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10.1. 
10.2. 
10.3. 
11. 

 
 
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Data analyses and publication will be conducted in collaboration between the Principal 
Investigator and Study Sponsor as outlined in the Contractual Agreement. 
 REFERENCES 
Bryson, G. & Wyand, A., 2006. Evidence-based clinical update: general anesthesia and the risk of delirium 
and postoperative cognitive dysfunction. Canadian journal of anesthesia, 53(7), p.669. 
Corbo, J. et al., 2005. Concordance Between Capnography and Arterial Blood Gas Measurements of Carbon 
Dioxide in Acute Asthma. Annals of Emergency Medicine, 46(4), pp.323–327. 
Doolke, A., 2001. The effects of lowering fresh gas flow during sevoflurane anesthesia: a clinical study in 
patients having elective knee arthroscopy. Ambulatory Surgery, 9(2), pp.95–98. 
Ekbom, K. et al., 2007. The effects of fresh gas flow on the amount of sevoflurane vaporized during 1 
minimum alveolar concentration anesthesia for day surgery: a clinical study. Acta anesthesiologica 
Scandinavica, 51(3), pp.290–3. 
Etzioni, D. a et al., 2003. The aging population and its impact on the surgery workforce. Annals of surgery, 
238(2), pp.170–7. 
Gao, L. et al., 2005. Postoperative cognitive dysfunction after cardiac surgery. Chest, 128(5), pp.3664–70. 
Konat, G.W., Kofke, W.A. & Miric, S., 2003. Toxicity of compound A to C6 rat glioma cells. Metabolic brain 
disease, 18(1), pp.11–5. 
Kummar, P. et al., 2009. Unusual Cause of Leak in Datex Aisys. Anesthesia & Analgesia, 109(4), p.1350. 
Lewis, M.C., 2007. Uncomplicated general anesthesia in the elderly results in cognitive decline: Does 
cognitive decline predict morbidity and mortality? Medical hypotheses, 68(3), p.484. 
Monk, T.G. et al., 2005. Anesthetic Management and One-Year Mortality After Noncardiac Surgery. 
Anesthesia Analgesia, 100(1), pp.4–10. 
Monk, T.G. et al., 2004. Can We Alter Long-Term Outcome ? The Role of Inflammation and Immunity in the 
Perioperative Period ( Part II ). Regional Anesthesia, 19(1), pp.1–16. 
Morio, M., 1992. Reaction of sevoflurane and its degradation products with soda lime: Toxicity of the 
byproducts. Anesthesiology, 77(6), p.1155. 
Rasmussen, L.S., 2006. Postoperative cognitive dysfunction: Incidence and prevention. Best Practice & 
Research Clinical Anesthesiology, 20(2), pp.315–330. 
Silverstein, J.H. et al., 2007. Postoperative cognitive dysfunction in patients with preoperative cognitive 
impairment: which domains are most vulnerable? Anesthesiology, 106(3), pp.431–5. 
Sodasorb, 1993. Manual of CO2 absorption. Library, pp.17–17. 
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Stabernack, C.R. et al., 2003. Sevoflurane degradation by carbon dioxide absorbents may produce more 
than one nephrotoxic compound in rats. Canadian Journal of Anesthesia, 50(3), pp.249–252. 
 APPENDICES 
 Appendix A: L-SOP-14001 Memsorb Device Installation and Basic Use Training 
Procedure and Attachment 1 
 Appendix B: Feeder List to Delegation and Signature Log 
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13. 
13.1. 
13.2.