Abdominal Compartment Syndrome, Intracranial Pressure Increase
Conditions
Brief summary
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.
Detailed description
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. 1. A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning urine collection, before insufflation of pneumoperitoneum 2. B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or lowest setting 3. C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15 mmHg 4. D) 10-15 minutes after desufflation of pneumoperitoneum and basal mechanical ventilation Measurements include : * Intraabdominal pressure IAP: assessed via laparoscopic insufflator, set at 15 mmHg as a standard value for all laparoscopic procedures * Intrathoracic pressure: indirectly measured by variability of peak expiratory pressures * Urine collection: through a Foley catheter from the beginning of surgery to post-operative day 1 * Urine osmolality (to be assessed at set time-points ) * Hourly urine output (at least 24 hours in order to evaluate expected significant variation even after the procedure end, since renal adaptation could take longer period) * Serum/plasma collection : blood draws to evaluate specific values of * Plasma Vasopressin (ADH) * Serum osmolality * Mean arterial pressure : standard of care * Pulmonary expiratory end-pressure (PEEP): anesthesiologists routinely adapt PEEP in order to maintain an optimal ventilation, especially in obese patients and during laparoscopy * Optic nerve sheath diameter (ONSD): a 7.5-MHz linear ultrasound probe to measure the diameter of the optic nerve sheath 3 mm behind the globe is going to be used; a trained study personnel physician will take the non-invasive sonographic picture using ultrasound. The ONSD will be measured from the captured picture. Study personnel will record the interaction on the patient's chart and include the measurement on the database
Interventions
DIAGNOSTIC_TESTStudy Arm
Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-72 * Patients meeting NIH criteria for bariatric surgery * Patients undergoing laparoscopic sleeve gastrectomy
Exclusion criteria
* • Age below 18 years * American Society of Anesthesiologist (ASA) class IV or V * Other evident/diagnosed causes of increased IAP or increased intrathoracic pressure, except for obesity * Active urinary tract infection * Previous or concomitant neurological disease * Previous or concomitant ophthalmic conditions/eye surgery * Previous or concomitant lung diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP | Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation) | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 10 |
| Body Mass Index (BMI) | 41.1 kg/m² STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed