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IleusNCT06338813

Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus

A study testing Digital Manometry in people with Ileus, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Ileus
What is being tested?
Digital Manometry
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2022to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara City Hospital

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Kron Technique and Digital Manometry for Intra-Abdominal Pressure Measurement in Emergency Department Patients Diagnosed With Ileus

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.

Conditions
Ileus
Being tested
Digital Manometry
Medical subject headings
Ileus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital ManometryDevice

    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.

Study groups in NCT06338813
Study groupRoleWhat they receive
Kron TechniqueNo interventionIntraabdominal pressure measurement with Kron Technique
Digital ManometryActive comparatorIntraabdominal pressure measurement with Digital Manometry
Receives: Device: Digital Manometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start30 Oct 2022
  3. Primary completion22 Feb 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06338813
Sponsor's protocol ID
Merve Unutmaz
Status last verified
Mar 2024
First submitted
19 Mar 2024
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Digital Manometry in people with Ileus, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digital manometer measuring for Intraabdominal Pressure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

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