Trial Outcomes & Findings for Vasopressin in Intraabdominal Pressure Elevation (NCT NCT03707054)
NCT ID: NCT03707054
Last Updated: 2026-04-29
Results Overview
The investigators will measure the intrabdominal pressure (IAP) pressure using the laparoscopic insufflator dial, the optic nerve sheath diameter (OSND) using an ultrasound which is a surrogate of the intracranial pressure (ICP), the variation of vasopressin levels, and the urine osmolality at baseline and during pneumoperitoneum. This is done in an effort to understand the compensatory measure used during pneumoperitoneum and abdominal compartment syndrome
COMPLETED
NA
16 participants
Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)
2026-04-29
Participant Flow
Sixteen adult patients undergoing elective laparoscopic sleeve gastrectomy for severe obesity were prospectively enrolled between 2017 and 2019 at Cleveland Clinic Florida. All participants provided written informed consent.
No randomization or allocation was performed. All enrolled patients underwent the same surgical procedure and intraoperative physiologic measurements at four predefined time points (baseline, pneumoperitoneum, elevated PEEP, and end). No patients were excluded after enrollment.
Participant milestones
| Measure |
Sleeve Gastrectomy Patients
Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin.
Study Arm: Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sleeve Gastrectomy Patients
n=16 Participants
Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin.
Study Arm: Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
|
|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 10.0 • n=16 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
|
Body Mass Index (BMI)
|
41.1 kg/m²
STANDARD_DEVIATION 4.4 • n=16 Participants
|
PRIMARY outcome
Timeframe: Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)Population: All 16 enrolled participants who underwent laparoscopic sleeve gastrectomy and had complete intraoperative physiologic measurements were included in the analysis.
The investigators will measure the intrabdominal pressure (IAP) pressure using the laparoscopic insufflator dial, the optic nerve sheath diameter (OSND) using an ultrasound which is a surrogate of the intracranial pressure (ICP), the variation of vasopressin levels, and the urine osmolality at baseline and during pneumoperitoneum. This is done in an effort to understand the compensatory measure used during pneumoperitoneum and abdominal compartment syndrome
Outcome measures
| Measure |
Study Arm
n=16 Participants
All participants were adult patients undergoing elective laparoscopic sleeve gastrectomy for severe obesity. Each patient served as their own control. During the operation, standardized physiologic measurements were taken at four intraoperative stages: (1) baseline before pneumoperitoneum, (2) pneumoperitoneum at 15 mmHg intra-abdominal pressure with PEEP 5 cm H₂O, (3) pneumoperitoneum with PEEP increased to 10 cm H₂O, and (4) after desufflation. Measurements included optic nerve sheath diameter, serum vasopressin, urine osmolality, urine output, Mean Arterial Pressure, and intrathoracic pressure. The study represents a single observational cohort without randomization.
|
|---|---|
|
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
Baseline
|
2.37 pg/ml
Standard Deviation 5.23
|
|
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
Pneumoperitoneum
|
45.48 pg/ml
Standard Deviation 16.83
|
|
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
PEEP Increased
|
54.75 pg/ml
Standard Deviation 16.18
|
|
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
End post Desufflation
|
31.57 pg/ml
Standard Deviation 18.04
|
Adverse Events
Study Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place