NCT04556877

Brief Summary

In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 7, 2020

Last Update Submit

September 18, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • optic nerve diameter

    measuring optic nerve diameter

    within 2 hours of admission

  • optic nerve diameter

    measuring optic nerve diameter

    at 6.hour

  • optic nerve diameter

    measuring optic nerve diameter

    at 12.hour

  • optic nerve diameter

    measuring optic nerve diameter

    at 24.hour

Study Arms (3)

Intraabdominal pressure under 12 mmHg

Patients with intraabdominal pressure under 12 mmHg

Procedure: Intraabdominal pressure and optic nerve diameters

Intraabdominal pressure between 12-20 mmHg

Patients with intraabdominal pressure between 12-20 mmHg

Procedure: Intraabdominal pressure and optic nerve diameters

Intraabdominal pressure over 20 mmHg

Patients with intraabdominal pressure over 20 mmHg

Procedure: Intraabdominal pressure and optic nerve diameters

Interventions

Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG

Intraabdominal pressure between 12-20 mmHgIntraabdominal pressure over 20 mmHgIntraabdominal pressure under 12 mmHg

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative patients followed in intensive care

You may qualify if:

  • Having had major abdominal surgery

You may not qualify if:

  • pregnant patients
  • Patients whose bladder catheter cannot be inserted
  • Patients with diagnosed or suspected brain death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 21, 2020

Study Start

June 15, 2018

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations