Trial Outcomes & Findings for Intra-abdominal Pressure in Peritoneal Dialysis Patients (NCT NCT02811640)
NCT ID: NCT02811640
Last Updated: 2020-11-18
Results Overview
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.
COMPLETED
12 participants
During laparoscopic surgery, up to 30 minutes
2020-11-18
Participant Flow
Two patients had to be excluded from the analysis due to difficulties zeroing the Stryker pressure monitor at the time of surgery.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Technology malfunction
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Participants
n=12 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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=12 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 15 • n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: During laparoscopic surgery, up to 30 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Study Participants
n=10 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
|
|---|---|
|
Intra-Abdominal Pressure (IAP)
15 mm Hg
|
-0.5 mm Hg
Standard Deviation 2.0
|
|
Intra-Abdominal Pressure (IAP)
10 mm Hg
|
-0.2 mm Hg
Standard Deviation 3.1
|
|
Intra-Abdominal Pressure (IAP)
5 mm Hg
|
-1.2 mm Hg
Standard Deviation 2.6
|
Adverse Events
Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Deborah Zimmerman
Ottawa Hospital Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place