Development of a Simplified Method to Measure Intra-abdominal Pressure in Peritoneal Dialysis Patients
Conditions: Peritoneal Dialysis
Sponsor: Ottawa Hospital Research Institute

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Development of a Simplified Method to Measure Intra-abdominal Pressure in Peritoneal Dialysis 
Patients 
Investigators: 
Deb Zimmerman (Nephrology, PI) 
Brian Blew (Urology, co-investigator) 
Daniel Corsi (Methods Centre Statistician, co-investigator) 
Hilary Meggison (Intensive Care, co-investigator) 
Jeff Warren (Urology, co-investigator) 
Tharshika Thangarasa (Medical Student, University of Ottawa) 
Pilot Study, 1 year 
NCT02811640 

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ABSTRACT 
BACKGROUND: Patients treated with peritoneal dialysis (PD) are at increased risk to develop 
mechanical complications such as dialysate leaks and hernias thought to be related to an increase 
in intra-abdominal pressure (IAP) secondary to the addition of dialysate to the abdomen. 
Resistance training has been shown to increase IAP but it is unclear in the general population and 
in patients treated with PD if this training increases the risk of developing hernias.  
AIMS/HYPOTHESES: We therefore propose this  pilot study in which our specific aim is to: 
1) Observe the difference in IAP pressure measurements that are obtained using the simple hand 
held Stryker pressure monitor via the PD catheter compared to the standard IAP measurements 
obtained with the insufflator at the time of PD catheter insertion. This tool will then be used as 
part of a future larger trial in which we will: 1) Measure IAP with resistance training in patients 
treated with PD; with and without dialysate, 2) Assess PD patient interest in participating in 
resistance training trials, and 3) Determine the appropriateness of the proposed resistance 
training program for this patient population. Our ultimate goal is to develop a randomized 
clinical trial to: 1) assess the impact of resistance training on quality of life and functional status, 
2) assess the risk of developing leaks/hernias, and 3) determine if there is an association between 
IAP during resistance training and subsequent hernia development.  
RESEARCH PLAN:  
Ten patients who are having a PD catheter inserted in the operating room and provide informed 
consent will undergo IAP measurements with the Stryker pressure monitor. Values will be 
compared to the insufflator at inflation pressures of 5, 10, and 15 mmHg. Bland Altman plots 
will be constructed and considered acceptable if the mean difference between the readings is 
5mmHg and 95% of the points fall within 2 standard deviations of the mean difference.  If the 
Stryker pressure monitor is not found to be appropriate for measuring IAP in PD patients, more 
complicated methods that have been used historically will be validated if necessary.  
IMPACT: After the initiation of dialysis, functional status declines. Sedentary life-style and low 
muscle strength are important predictors of mortality for patients treated with dialysis. Yet 
patients treated with PD are advised not to participate in resistance training programs for fear of 
hernia development.  Ultimately, our research program has the potential to help many patients 
with end stage kidney disease to remain active if we are able to define the risks and benefits of 
an appropriately designed resistance training program. 

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1.1 Overview 
Patients with end stage kidney disease (ESKD) are at increased risk to develop functional 
impairment after the initiation of dialysis. Resistance training has been shown to improve muscle 
strength and self-esteem in other chronic diseases but has been not been studied in patients with 
ESKD treated with peritoneal dialysis (PD). The reasons for this may be multifactorial but 
almost certainly include concerns about increasing the risk for developing hernias.  
1.2 Hypothesis and Long Term Objectives 
Hypothesis: The observed intra-abdominal pressure (IAP) as assessed by the Stryker pressure 
monitor via the PD catheter will be similar to the IAP measured by the insufflator at the time of 
PD catheter insertion. If this hypothesis is correct, we will develop a future resistance training 
program for PD patients as part of a randomized clinical trial to: 1) assess the impact of 
resistance training on quality of life and functional status, 2) assess the risk of developing 
leaks/hernias, and 3) determine if there is an association between IAP during resistance training 
and subsequent hernia development.  
1.3 Background Rationale: Current state of knowledge 
1.3.1 Risk of Hernias in the General Population 
A hernia is a general term referring to a protrusion of a tissue through the wall of the cavity in 
which it is normally contained. In the First National Health and Nutrition Examination Survey, 
13.9% of men and 2.1% of women developed an inguinal hernia after a median follow-up of 
18.2 years.1 For men and women, inguinal hernias were associated with increased age and 
history of other hernias. In a separate case-control study of 1418 male patients with inguinal 
hernias, only a positive family history of inguinal hernias was important.2 The importance of 
weight lifting/resistance training as a cause of hernias was not addressed in any of the studies. 
1.3.2 Risk of Hernias for Patients with End Stage Kidney Disease Treated with Peritoneal 
Dialysis 
Patients treated with PD may develop dialysate fluid leaks especially around the site of the 
peritoneal dialysis catheter and/or hernias typical of the general population. In one small study of 
142 patients treated with PD over 5 years, 53 patients developed either a leak or hernia.3 The 
independent risk factors for peri-catheter leak and hernias were higher body mass index and 
polycystic kidney disease respectively. Importantly, the percentage of patients with hernias prior 
to starting PD was not reported. The majority of hernias develop early after the initiation of PD 
raising the possibility of pre-existing abdominal wall defects that become obvious with the 
increase in intra-abdominal pressure associated with PD.4,5 In a study of 122 patients, 19 hernias 
were detected in 15 patients prior to starting PD; 7 new hernias were detected during an average 
follow-up of 2 years after starting PD.6 The authors did not discuss if the hernias pre/post 
dialysis were in the same patients. In a more recent study, the only statistically significant risk 
factor for developing a hernia after starting PD was the occurrence of a hernia prior to dialysis 
(p=0.01).7 History of lifting was not assessed in any of the studies. Despite a lack of compelling 
evidence, patients treated with PD are advised not to participate in heavy lifting in order to 
reduce the risk of increased intra-abdominal pressure with activity.8-11
1.3.3 Methods to Measure IAP 
Methods to measure IAP have been developed for very diverse reasons including monitoring for 
the development of intra-abdominal compartment syndrome. Patients at high risk for 
development of the syndrome are monitored approximately every 8 hours via bladder pressure 
measurements. This technique was originally described by Iberti et al in 1989.12 The 
investigators described a comparison of IAP measured directly via paracentesis or through a 

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Jackson Pratt drain to values obtained via a foley catheter. The 2 methods of IAP measurement 
were highly correlated (r=0.91). Two other groups of investigators have compared direct IAP 
measurements using different techniques to those obtained from the insufflator during 
surgery.13,14 In one study, the comparator was a round PVC drain connected to an arterial blood 
pressure set. The correlation between the two measurements was excellent (0.97).13 In the second 
study, direct pressure measurement using the Stryker intracompartmental pressure monitor was 
described.14 The system used in the study consisted of a monitor (STIC), a sterile disposable 
indwelling slit catheter set with extension tubing and an introducing needle that is attached to the 
continuously reading monitor. The pressure measurements obtained by the STIC monitor 
correlated very well with the pressure measurements of the insufflator used during laparoscopic 
surgery with a mean difference between the 2 techniques of 0.04±3.8mmHg.  
Very few studies actually report IAP measurements in patients treated with PD. In the first study, 
IAP was assessed using a CVP monometer connected to an outflow line and estimated at the 
level of the umbilicus in supine position.15 IAP increased from 0.37 to 1.10mmHg in a linear 
fashion with increasing volumes of dialysate. In 1983 using a similar measurement technique, 
Twardowski and colleagues estimated IAP with a CVP manometer connected to the dialysis 
catheter from the level of the umbilicus in the supine position and xiphoid process in the sitting 
and standing positions.16 They demonstrated: 1) an increase in IAP with increasing volumes of 
dialysate, and 2) IAP was influenced by position. After modifying their technique to include 
continuous monitoring with a pressure transducer connected to the PD catheter via a 3 way stop 
cock, this same group of investigators measured IAP with ‘normal’ activity including jogging, 
cycling, jumping, lifting (0, 11.4 and 22.8kgs), coughing and straining with dialysate volumes 
increasing from 0 to 3L.17 Coughing and straining were associated with the greatest IAP with 
pressures as high as 230mmHg recorded (Figure 1). IAP increased with increasing weight lifted 
to a maximum of about 100mmHg with little difference between the different dialysate volumes 
with weights lifted of 11.4 and 22.8kgs. Using a slightly different technique in which IAP was 
estimated at the centre of abdomen in the mid-axillary line, no difference in ‘resting’ pressures 
was detected between patients with and without mechanical complications such as hernias.18
This was not true for children in which those with mechanical complications had a slightly 
higher resting IAP.19
1.3.4 Patients with End Stage Kidney Disease and Loss of Functional Status 
After the initiation of dialysis, functional status declines. In a study of nursing home residents, 
the Minimum Data Set–Activities of Daily Living scale increased from 12 in the 3 months prior 
to starting dialysis to 16 during the 3 months after starting dialysis with higher numbers 
reflecting greater functional difficulty.20 At 12 months post dialysis initiation, 58% of the 
patients had died and only 13% had maintained their pre-dialysis functional status. Of elderly 
patients already on dialysis, approximately 50% require assistance with personal care which is 
compounded by losses of muscle strength during periods of hospitalization.21 In a nutritional 
study of patients treated with CAPD, women were found to have significant weight loss related 
to muscle wasting.22 Importantly, sedentary life-style and low muscle strength are important 
predictors of mortality for patients treated with dialysis.23-26
1.3.5 Benefits of Resistance Training in Patients with Chronic Diseases 
The supervised trial of aerobic versus resistance training was the first study in women with 
breast cancer being treated with chemotherapy.27 Resistance training was found to increase self-
esteem, muscular strength and lean body mass. In a recent meta-analysis of cancer survivors, 
resistance training of low to moderate intensity was associated with clinically important effects 

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on muscle function and body composition.28Resistance training has also been shown to be of 
benefit with respect to muscle strength in men with chronic obstructive pulmonary disease, 
patients with congestive heart failure and may be the training modality of choice in the frail 
elderly for the maintenance of activities of daily living.29-31 Additional benefits of resistance 
training include improved glycemic control, blood pressure and serum triglyceride levels which 
may offer additional cardiovascular benefits to patients treated with peritoneal dialysis.31
In hemodialysis, a few small studies have examined the impact of resistance training on a variety 
of outcomes. In a 12-week intra-dialytic resistance training program for 10 hemodialysis 
patients, there was a statistically significant improvement in the performance of the 6 minute 
walk test, normal and maximal gait speed and time to complete a sit-stand test 10 times.32
Muscle strength has also been shown to increase with resistance training in patients treated with 
hemodialysis.33-35 To our knowledge, there haven’t been any studies of resistance training in 
peritoneal dialysis patients. It is unclear if this is secondary to: 1) more difficult patient 
population to study than patients treated with hemodialysis, or 2) concerns about mechanical 
complications such as hernias in the peritoneal dialysis population.  
Summary of the Available Evidence 
Patients treated with peritoneal dialysis are at increased risk to develop mechanical 
complications such as dialysate leaks and hernias thought to be related to an increase in IAP 
secondary to dialysate. Weight lifting has been shown to increase IAP but it is unclear in the 
general population and in patients treated with peritoneal dialysis if resistance training actually 
increases the risk of developing hernias. However, it is clear that there are physical and 
psychological benefits associated with resistance training that may be of particular importance to 
patients treated with peritoneal dialysis. Currently IAP is not measured routinely in PD patients 
except at the time of catheter insertion and there is not an accepted ‘standard’ way to measure 
IAP for research in PD patients. We therefore propose this study in which we will develop an 
easy to use method to measure IAP in patients treated with PD such that this technique could be 
easily applied in future clinical care and research studies.  
SECTION 2: TRIAL DESIGN 
2.1 Inclusion Criteria 
Adult patients (≥18 years old) with chronic kidney disease that will have a PD catheter inserted 
in the operating room at the Ottawa Hospital using laparoscopic surgery. Able and willing to 
give informed consent. 
2.2 Exclusion Criteria  
Patients who will have a non-standard PD catheter insertion position (eg parasternal)  
2.3 Study Protocol 
Basic demographic information will be collected including: age, sex, height, weight, comorbid 
illnesses and cause of kidney failure.  
Development of a Simple IAP measurement technique 
The Stryker intracompartmental monitor is a simple to use, hand-held, portable device that 
would make it ideal for a multicentre study in which IAP could be measured in a large number of 
patients in diverse research/clinic environments.  The pressure monitor system was developed to 
detect compartment syndrome and includes a small pressure monitor and a sterile fluid path that 
includes a side-ported needle (https://www.stryker.com/en-
us/products/SurgicalEquipment/PressureMonitors/IntraCompartmentalPressureMonitor/index.ht
m). For our purposes, the pressure system (without the side port needle) would be directly 
connected to the PD catheter via sterile extension tubing as described below (Figure 2).  

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Standard cannulation of the abdomen by the surgeon will be undertaken followed by insufflation, 
insertion of trochars as required and placement of the internal portion of the PD catheter in the 
true pelvis. The PD catheter will be flushed with normal saline or lactated ringers. Then the 
external portion of the catheter will be connected to the Stryker monitor using sterile extension 
tubing. With the patient at end-expiration (typical of lifting), the pressure measured from the PD 
catheter at the level of the umbilicus in the mid-axillary line will be compared to the insufflator 
at 15, 10 and 5mmHg. If the easy to use Stryker pressure monitor is found to be inappropriate for 
our purpose (see data analysis), the standard IAP measurement that has been developed for foley 
catheters and modified for PD catheters in the past will be used. Briefly, the PD catheter will be 
flushed with normal saline or lactated ringers as above and connected to a transfer set and 
TEGO® adapter. The TEGO® will then be connected to arterial tubing, a pressure transducer 
and a pressure monitor (present in the operating room). This is the same type of set up that is 
used in the intensive care unit with the exception that the pressure transducer and arterial tubing 
are connected to the sampling port of the foley catheter. With the patient at end-expiration, the 
pressure measured from the PD catheter zeroed at the level of the umbilicus in the mid-axillary 
line will be compared to the insufflator at 15, 10 and 5mmHg.  
2.5 Sample Size and Analysis 
Summary descriptive statistics to describe the patient population will be calculated. The 
proportion of screened patients that are: 1) eligible, and 2) agree to participate will be 
determined. We will recruit 12 participants. Bland Altman plots will be constructed and 
considered acceptable if the mean difference between the readings is 5mmHg and 95% of the 
points fall within 2 standard deviations of the mean difference. Based on previous literature, 
correlation coefficients will also be assessed and considered acceptable if the calculated value is 
greater than 0.9. If these targets are not met, the first phase will be repeated using the arterial 
tubing, pressure transducer and pressure monitor as has been used historically.  
2.6 Time Lines and Feasibility 
Last year, Drs Warren and Blew inserted 123 PD catheters laparoscopically; 49 of these catheters 
were left exteriorized and would have had transfer sets connected to them. Typically there are 2 
surgical days/month with about 5 patients per day. The time needed to do the IAP measurements 
is very small and will not affect OR flow such that up to 5 patients could be tested in a single OR 
day. Allowing for time for REB approval, recruitment of patients and data-analysis – the study is 
anticipated to take approximately one year.  
2.7 The Research Team 
Dr Zimmerman is a nephrologist at the Ottawa Hospital and a clinician investigator with the 
KRC and OHRI. She has a MSc in clinical epidemiology and extensive clinical research 
experience. Dr Meggison is an intensivist at the Ottawa Hospital and has experience with the 
measurement of intra-abdominal pressure. She will provide clinical expertise and assistance with 
intra-abdominal pressure monitoring. Drs Jeff Warren and Brian Blew are urologists at the 
Ottawa Hospital. They are responsible for insertion of all of the PD catheters for the Ottawa 
Hospital Home Dialysis Program. They will assist in the coordination of PD catheter insertion 
and IAP measurements. Dr Dan Corsi has a PhD in Epidemiology and Population Health from 
McMaster University. He is a statistician with the Methods Centre of the Ottawa Hospital 
Research Institute. He was responsible for our sample size calculations and he will oversee all 
statistical analysis at the completion of the study. Tharshika Thangarasa is a medical student with 
funding support from the University of Ottawa; this will serve as her summer project. 

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Figure 1: Intra-abdominal pressure in PD patients with different activities 
Figure 2: Stryker Pressure Monitor Connected to a PD catheter