Intra-Abdominal Hypertension Clinical Trial
Official title:
Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Correlation of IAP measurements with clinical status of the neonatal abdomen will help determine threshold values for Intra-Abdominal Hypertension (IAH) in the neonate.
An increasingly common cause of Multiple Organ Dysfunction Syndrome (MODS) is mechanical
injury/ischemia caused by elevated pressures within the abdominal cavity. This phenomenon
has been termed intra-abdominal hypertension (IAH) with the final pathway of multiple organ
dysfunction and failure termed abdominal compartment syndrome (ACS). In the neonate, IAH is
known to accompany omphalocele, gastroschisis and diaphragmatic hernia repair. IAH has also
been found to cause a need for neonatal extra corporeal membrane oxygenation (ECMO) and/or a
subsequent failure of ECMO treatment.
While abdominal compartment syndrome is the final physiologic and clinically apparent
expression of severe elevations of intra-abdominal pressure, earlier in the course of this
process, significant organ dysfunction occurs at a sub-clinical level. If mild to moderately
elevated abdominal pressure can be detected early, it may allow clinicians to intervene
early and reverse the process, preventing progression to ACS and possibly reducing morbidity
and mortality.
To date no study has investigated the correlation between bladder pressure (a surrogate
measure of IAP) in neonates who may or may not have ACS. Thus, the ranges of normal and
elevated IAP are not determined. There is suggestion from pediatric ICU patients that the
threshold for IAH in children is less than that in adults. Likewise, the threshold for IAH
in neonates may be expected to be even lower, but this remains to be determined.
In this study, IAP (via bladder pressure measurements) will be measured with a commercially
available and FDA approved system which utilizes an electronic pressure transducer, tubing,
and any bedside patient monitor with pressure measurement inputs. These types of monitors
are standard in the NICU. The pressure transducer is attached to the bladder catheter via a
two-way valve, allowing urine drainage in-between taking bladder pressure measurements. A
small amount of sterile saline is infused into the bladder in order to make the IAP
measurement. While there is an indwelling urinary catheter, bladder pressure measurements
will be taken every 2-4 hours.
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Observational Model: Cohort, Time Perspective: Prospective
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