Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338813
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-19
Brief Title:
Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Comparison of the Kron Technique and Digital Manometry for Intra-Abdominal Pressure Measurement in Emergency Department Patients Diagnosed With Ileus
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 others 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 07355 mmHg During the measurements the patients treatment plan was not interrupted
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 07355 mmHg During the measurements the patients treatment plan was not interrupted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None