Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus

NCT06338813 | Completed FDA Device

• 1 other identifier: Merve Unutmaz
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Although many measurement techniques have been tried for intra-abdominal pressure, the Kron technique is currently the gold standard method. However, the search for other methods continues due to its long application time, the need for more equipment, and impracticality. Consequently, the investigators sought to investigate a quicker and more accessible method suitable for successful intra-abdominal pressure measurement in the emergency department. This study aimed to compare intra-abdominal pressure measurements in patients diagnosed with ileus using a digital manometer and the Kron Technique.

Conditions

Ileus

Outcome Measures

Primary Outcomes (1)

• Digital manometer measuring for Intraabdominal Pressure

  Compare the Kron technique, which is a more complex method but considered the gold standard, with Intraabdominal Pressure measurement using a digital manometer

  30 minutes

Study Arms (2)

Kron Technique

NO INTERVENTION

Intraabdominal pressure measurement with Kron Technique

Digital Manometry

ACTIVE COMPARATOR

Intraabdominal pressure measurement with Digital Manometry

Device: Digital Manometry

Interventions

Digital Manometry DEVICE

The "Compass Lumbar Puncture Pressure Transducer" (Mirador Biomedical, Seattle, WA, USA) was used as a digital manometer. After the bladder was completely emptied, the catheter was clamped again. 25 cc of sterile saline was injected into the bladder through the urine sample port. The digital manometer was connected to the urine sample port. The IAP value in cmH2O on the digital screen of the device was noted.

Digital Manometry

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• Diagnosis of ileus was confirmed by radiological imaging (radiography and Computed Tomography)

You may not qualify if:

• Patients who underwent any decompressive procedure before the measurement (Nasogastric catheter, enema)
• Patients who could not be urine catheterized
• Patients who could not be placed in the supine position (advanced heart failure, kyphosis, etc.)
• Uncooperative patients (Alzheimer's, dementia, mental retardation, etc.)
• Patients with morbid obesity (body mass index \> 40 kg/m2), ascites, or pregnancy
• Patients who have undergone bladder surgery
• Patients with neurogenic bladder

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Çağdaş Yıldırım

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 1, 2024
• Study Start: October 30, 2022
• Primary Completion: February 22, 2023
• Study Completion: March 1, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

TU (1)