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CompletedNCT06338813Updated Apr 1, 2024

Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus

An interventional study of Digital Manometry in Ileus, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was Feb 2023, 3 years 8 months ago, and no results have been posted to the registry.
  • Registered 1 year 4 months after the study started (first participant enrolled Oct 2022, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

Before the start of the study, the Kron Technique and IAP measurement with a digital manometer were demonstrated both didactically and practically to 4th year Emergency Medicine residents. It was ensured that any two of these residents were continuously present on the monthly duty roster. When a patient who met the inclusion criteria presented to the emergency department, the residents were separately invited to the bedside for measurements by the attending physician without each other's knowledge. After the attending physician obtained information about the patient, the exclusion criteria were evaluated. After the patient was deemed eligible, the attending physician explained the application and the study to the patient in detail. Informed consent was obtained from the patients both verbally and in written. Demographic information (age, gender) and medical history were recorded.

Measurements were performed with the patient in the supine position. A transurethral Foley catheter (16 Fr) was inserted by the attending physician under sterile conditions. First, IAP was measured using the 'Kron technique.' The connection hose of the urine collection container was attached to the Foley catheter. The hose was clamped after the urine in the bladder was completely emptied. A sterile three-way tap was attached to the urine sample port in the connection hose. From the three-way tap, 25 ml of sterile saline was injected into the bladder with a syringe. Subsequently, one end of the transducer interconnection cable was connected to the three-way tap, and the other end was connected to the bedside monitor (GE B40 V3 bedside monitor, Germany). Subsequently, pressure adjustments were reset on the monitor, and IAP was recorded in mmHg. After this measurement, a digital manometer was used. This measurement was performed by the second resident. The "Compass Lumbar Puncture Pressure Transducer" (Mirador Biomedical, Seattle, WA, USA) was used as a digital manometer (Figure 2). 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. The IAP measurement value recorded in cmH2O was converted to mmHg using the equation "1 cmH2O = 0.7355 mmHg." During the measurements, the patient's treatment plan was not interrupted.

02

Conditions studied

  • Ileus

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03

In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 138 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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 ( > 40 kg/m2), ascites, or pregnancy
    • Patients who have undergone bladder surgery
    • Patients with neurogenic bladder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Kron Technique

    Intraabdominal pressure measurement with Kron Technique

  • Active comparator
    Digital Manometry

    Intraabdominal pressure measurement with Digital Manometry

    Device: Digital Manometry

Interventions

  • DeviceDigital Manometry

    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.

06

What researchers measure

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

    Time frame: 30 minutes

07

Study locations

1 site
  • Ankara City Hospital
    Ankara, 06100, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Feb 2023, 3 months.

Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's 3 months is below that.

Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2024
First posted
Apr 1, 2024
StartActual
Oct 30, 2022
Primary completionActual
Feb 22, 2023
CompletionActual
Mar 1, 2023
Last update
Apr 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06338813
Responsible party
Cagdas Yildirim, MD (Asistant Professor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Apr 1, 2024
Start date
Oct 30, 2022
Primary completion
Feb 22, 2023
Completion
Mar 1, 2023
Last update
Apr 1, 2024

Study contacts

Çağdaş Yıldırım
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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