Peritoneal Dialysis
Conditions
Keywords
Intra-Abdominal Pressure, Stryker Pressure Monitor
Brief summary
Patients treated with peritoneal dialysis (PD) are at increased risk of developing 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. This study is observing the difference in IAP pressure measurements obtained by the Stryker intracompartmental (STIC) pressure monitor versus the standard IAP pressure measurements obtained with the insufflator at the time of PD catheter insertion.
Detailed description
Ten patients who are having a peritoneal dialysis (PD) catheter inserted at the Ottawa Hospital, and who provide informed consent, will undergo intra-abdominal pressure (IAP) measurements with the Stryker intracompartmental (STIC) pressure monitor. Values will be compared to the insufflator at inflation pressures 5,10, and 15 mmHg (millimeters of mercury). To determine if the Stryker pressure monitor is appropriate for measuring IAP in PD patients, the observed pressures will be analyzed with Bland Altman plots. If the mean difference between readings is 5 mmHg and 95% of the points fall within 2 standard deviations of the mean difference, the Stryker pressure monitor will be considered an acceptable method of measuring IAP. This tool will then be used as part of a future larger trial which 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. The ultimate goal is to use this study to help inform and develop a 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
Interventions
OTHERStudy Participants
IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion
Sponsors
Ottawa Hospital Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years old) * Chronic kidney disease * Will have a PD catheter inserted in the operating room at the Ottawa Hospital using laparoscopic surgery
Exclusion criteria
* Patients who will have a non-standard PD catheter insertion position (eg parasternal)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-Abdominal Pressure (IAP) | During laparoscopic surgery, up to 30 minutes | The Intra-Abdominal Pressure (IAP) measured with the Stryker monitor connected to the peritoneal dialysis (PD) catheter was compared with the insufflator pressures at of 15, 10, and 5 mm Hg. |
Countries
Canada
Participant flow
Pre-assignment details
Two patients had to be excluded from the analysis due to difficulties zeroing the Stryker pressure monitor at the time of surgery.
Participants by arm
| Arm | Count |
|---|---|
| Study Participants Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital
Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Technology malfunction | 2 |
Baseline characteristics
| Characteristic | Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 53 years STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 12 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Intra-Abdominal Pressure (IAP)
The Intra-Abdominal Pressure (IAP) measured with the Stryker monitor connected to the peritoneal dialysis (PD) catheter was compared with the insufflator pressures at of 15, 10, and 5 mm Hg.
Time frame: During laparoscopic surgery, up to 30 minutes
Population: There is only 1 arm or group for this study. The study participants are adults with chronic kidney disease who had a PD catheter inserted at the Ottawa Hospital. During the insertion, IAP was observed and measured with a hand held Stryker Pressure Monitor and with the insufflator. These results were compared, and the average difference and the standard deviation between the two are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants | Intra-Abdominal Pressure (IAP) | 15 mm Hg | -0.5 mm Hg | Standard Deviation 2 |
| Study Participants | Intra-Abdominal Pressure (IAP) | 10 mm Hg | -0.2 mm Hg | Standard Deviation 3.1 |
| Study Participants | Intra-Abdominal Pressure (IAP) | 5 mm Hg | -1.2 mm Hg | Standard Deviation 2.6 |