Prospective observational study to optimize and simplify the diagnosis of pathologically increased intra-abdominal pressure in critically ill childre

Recruiting

• Conditions: R19.0; R10.0; Intra-abdominal and pelvic swelling, mass and lump; Acute abdomen

• Registration Number: DRKS00006556
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

All term infants and pediatric patients between 0 and 18 years of life who are taken to the interdisciplinary pediatric intensive care unit of the Medical University of Hannover and who need anyway - due to their illness or treatment - an abdominal drainage (wound or ascites drainage, peritoneal dialysis catheter etc.) and a gastric tube and / or a urinary catheter might be included in this study. For this purpose, patients and parents are informed in detail about the nature, meaning and objectives of the study and must have expressly agreed to their participation and transmitted a written consent form before the start of measurements. Against the background of nasopharyngeal and esophagogastric proportions formerly preterms can not be included in the study before reaching the expected delivery date in cases of then newly emerging risk factors and new-onset intra-abdominal hypertension.
Preferably, IAP should be measured in children and adolescents at risk for the development of intra-abdominal hypertension (IAH). Related risk factors include all disease entities associated with a pathology and especially inflammation of the abdominal and retroperitoneal spaces or therein located organs and tissues (eg, peritonitis, perforation, pancreatitis, ileus, volvulus, necrotizing / infectious enterocolitis, hemorrhage, tumor / space-occupying processes). Abdominal wall closures (in cases of congenital abdominal wall or diaphragmatic hernia) and large-for-size organ transplants are considered prototypes of IAH-inducing diseases, since the intra-abdominal filling volume required for a tension-free abdominal closure is insufficient (especially in neonatal patients). Intra-parenchymal and cavitary fluid collections that are observed particularly in the context of capillary leak due to sepsis and systemic inflammation are the most common cause group for IAH and ACS in childhood [Beck 2001]. In addition, hypothermia, positive balance, (mass) transfusions, mechanical ventilation, hypotension and acidosis could be identified as general risk factors for the development of IAH and ACS [Holodinsky 2013, Malbrain 2013].

Exclusion Criteria

Against the background of nasopharyngeal and esophagogastric size ratios preterm infants (Also excluded are all pediatric patients who have a disease entity of the nasopharynx and / or the upper gastrointestinal tract. These include in particular those children who need surgery or differentiated interventional as well as non-surgical therapies such as dilatation or radiation due to injury, disease or deformity in these areas or have already been operated or treated, respectively. In children and adolescents with a known, suspected or contemporaneous disturbance of the gastric muscle tone as well as following esophageal or gastric surgery (especially anastomosis in esophageal atresia, stomach pull-up, fundoplication or placement of percutaneous endoscopic gastrostomy) no reliable intra-gastric pressure measurement can be expected.
Children and young people with a known or suspected neurogenic bladder dysfunction can be included in the study; however, due to the imperfection of measured intra-vesical pressures bladder pressure measurements must be omitted. All other parameters can be determined, correlated and statistically analyzed.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of directly measured intra-abdominal pressures with indirect measuring methods (via the stomach and bladder) and assessment in terms of accuracy (goodness of fit), sensitivity and practicality. Using gastric tubes the IAP can be determined continuously; via the bladder or using direct accesses, however, the IAP can be examined only intermittently. The proposal provides for hourly documentation of continuous readings and a two-hourly collection and documentation of discontinuous IAP-values.