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The aim of this study is to investigate any direct correlation between increased intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). The second end-point is to investigate any correlation between elevated intracranial pressure and vasopressin release, urine output and urine and serum osmolality by measuring their values at different time-points.
Increase in intraabdominal pressure (IAP) has been demonstrated to correlate with consequential hemodynamic effects. Several studies have been carried out mostly in experimental settings to define the underlying mechanisms that regulate the pathophysiology following an increase in IAP. In the last years this topic has become concerning because of the wide spread of laparoscopy, that is namely an iatrogenic acute increase in IAP.
Patients selected and consented for elective surgery will undergo standard of care and additional measurements during and after surgery. The measurements will be done at different stages of laparoscopic surgery.
Measurements include :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Arm | Diagnostic Test | Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP | 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 | Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation) |
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Inclusion Criteria:
Exclusion Criteria:
• Age below 18 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean ± standard deviation of participants' age at baseline. All participants were adult patients undergoing elective laparoscopic sleeve gastrectomy. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP | 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 | All 16 enrolled participants who underwent laparoscopic sleeve gastrectomy and had complete intraoperative physiologic measurements were included in the analysis. | Posted | Mean | Standard Deviation | pg/ml | Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation) |
|
Adverse event data were collected during the intraoperative period only (from induction of anesthesia through completion of desufflation), approximately 1 hour.
Adverse events were not systematically collected for this physiological observational study. No protocol-specific definitions differing from ClinicalTrials.gov were used. Participants underwent standard laparoscopic sleeve gastrectomy, and only intraoperative physiologic measurements were recorded. No adverse events were observed or reported during the intraoperative data collection period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm | Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin. Study Arm: Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Lo Menzo | Cleveland Clinic Florida | 9546595249 | lomenze@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol with Satatisical plan | Jan 16, 2019 | Dec 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2019 | Dec 16, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003161 | Compartment Syndromes |
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prospective trial
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Distribution of participants by biological sex at baseline. All participants underwent sleeve gastrectomy. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
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.
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|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |