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).
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.
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 group | Role | What they receive |
|---|---|---|
| Kron Technique | No intervention | Intraabdominal pressure measurement with Kron Technique |
| Digital Manometry | Active comparator | Intraabdominal 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.
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.
- First posted1 Apr 2024
- Study start30 Oct 2022
- Primary completion22 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Yildirim, MD, Ankara City Hospital Bilkent
- Investigators
- Çağdaş Yıldırım, Principal investigator, Ankara City Hospital Bilkent
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Kron Technique and Digital Manometry for Intra-Abdominal Pressure Measurement in Emergency Department Patients Diagnosed With Ileus
- ClinicalTrials.gov ID
- NCT06338813
- Acronym / sponsor ID
- Merve Unutmaz
- Conditions
- Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kron Technique | No intervention | –Intraabdominal pressure measurement with Kron Technique |
| Digital Manometry | Active comparator | Device: Digital ManometryIntraabdominal pressure measurement with Digital Manometry |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- Diagnosis of ileus was confirmed by radiological imaging (radiography and Computed Tomography)
Key exclusion criteria (7 listed)
- Patients who underwent any decompressive procedure before the measurement (Nasogastric catheter, enema)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital ManometryThe "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. | Device | Digital Manometry |
Primary outcome
Digital manometer measuring for Intraabdominal Pressure
Time frame: 30 minutes
Compare the Kron technique, which is a more complex method but considered the gold standard, with Intraabdominal Pressure measurement using a digital manometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çağdaş Yıldırım principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
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.