Intraabdominal HypertensionPhase 3GhadaNCT02639013
an Educational Program About Abdominal Compartment Syndrome
A Phase 3 study testing transducer technique in people with Intraabdominal Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
Early detection of intra-abdominal hypertension is essential to the prevention of abdominal compartment syndrome and requires close surveillance of intra-abdominal hypertension in patients at increased risk. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraabdominal Hypertension
- What is being tested?
- transducer technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Oct 2016
- Phase
- Phase 3
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all nurses that have more than one years experience in the trauma ,general and gastrointestinal ICU
Who cannot join
- nurses less than one year experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Trend Analysis of Nurse's Knowledge and Practice Before and After Implementing an Educational Program Regarding Abdominal Compartment Syndrome
Early detection of intra-abdominal hypertension is essential to the prevention of abdominal compartment syndrome and requires close surveillance of intra-abdominal hypertension in patients at increased risk. intra-abdominal hypertension measurements are often taken by the bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension monitoring is prompted by critical care nurses.
Read the detailed description
Measurement of intra-abdominal pressure is simple, inexpensive, safe and accurate method in determining the presence of intra-abdominal hypertension. This measurement can guide patient management. Monitoring intra-abdominal pressure and abdominal per-fusion pressure.
for signs of abdominal compartment syndrome has become an inexpensive and useful diagnostics tool for identifying complications. An integrated approach to screening and monitoring for intra-abdominal hypertension may improve patient outcomes and decrease hospital costs. Due to the high incidence of intra-abdominal hypertension and abdominal compartment syndrome, it is essential for critical care nurses to regularly monitor intra-abdominal pressure and abdominal per-fusion pressure.
Critical care nurses have the ability to identify intra-abdominal hypertension and abdominal compartment syndrome, implement and evaluate management interventions. Nursing practice should be centered on evidence based practice guidelines . Nurses should provide a standard of care in managing patients who are at risk of intra-abdominal hypertension and abdominal compartment syndrome from pre hospital, emergency, operating room and intensive care areas
- Conditions
- Intraabdominal Hypertension
- Being tested
- transducer technique
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transducer techniqueProcedure or surgery
Also called monitoring intraabdominal pressure
the nurses will receive the intervention ( the transducer method) to measure intraabdominal pressure intraabdominal hypertension and how to measure intraabdominal pressure in the third section
| Study group | Role | What they receive |
|---|---|---|
| ttransducer technique | Experimental | the nurses will measure intraabdominal pressure at each shift during the day by using transducer technique Receives: Procedure: transducer technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve nurses knowledge and practice about abdominal compartment syndrome
pretest and post questionaire will be used to evaluate the improvement in nurses knowledge and practice about abdominal compartment syndrome
Measured: 6 months
Secondary outcomes (1)
prevent abdominal compartment syndrome
measure inta-abdominal pressure correctly and continuously monitor signs of increased intrabdominal pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraabdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Shalaby, Assiut University
- Investigators
- Ghada Sh Khalaf, Lecturer, Principal investigator, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639013
- Sponsor's protocol ID
- AAH100
- Acronym
- Ghada
- Status last verified
- Nov 2015
- First submitted
- 17 Dec 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newcombe J, Mathur M, Bahjri K, Ejike JC. Pediatric critical care nurses' experience with abdominal compartment syndrome. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S6. doi: 10.1186/2110-5820-2-S1-S6. Epub 2012 Jul 5.
PubMed 22873422Hunt L, Frost SA, Hillman K, Newton PJ, Davidson PM. Management of intra-abdominal hypertension and abdominal compartment syndrome: a review. J Trauma Manag Outcomes. 2014 Feb 5;8(1):2. doi: 10.1186/1752-2897-8-2.
PubMed 24499574
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Trend Analysis of Nurse's Knowledge and Practice Before and After Implementing an Educational Program Regarding Abdominal Compartment Syndrome
- ClinicalTrials.gov ID
- NCT02639013
- Acronym / sponsor ID
- Ghada / AAH100
- Conditions
- Intraabdominal Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- 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.
Early detection of intra-abdominal hypertension is essential to the prevention of abdominal compartment syndrome and requires close surveillance of intra-abdominal hypertension in patients at increased risk. intra-abdominal hypertension measurements are often taken by the bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension monitoring is prompted by critical care nurses.
Detailed description
Measurement of intra-abdominal pressure is simple, inexpensive, safe and accurate method in determining the presence of intra-abdominal hypertension. This measurement can guide patient management. Monitoring intra-abdominal pressure and abdominal per-fusion pressure.
for signs of abdominal compartment syndrome has become an inexpensive and useful diagnostics tool for identifying complications. An integrated approach to screening and monitoring for intra-abdominal hypertension may improve patient outcomes and decrease hospital costs. Due to the high incidence of intra-abdominal hypertension and abdominal compartment syndrome, it is essential for critical care nurses to regularly monitor intra-abdominal pressure and abdominal per-fusion pressure.
Critical care nurses have the ability to identify intra-abdominal hypertension and abdominal compartment syndrome, implement and evaluate management interventions. Nursing practice should be centered on evidence based practice guidelines . Nurses should provide a standard of care in managing patients who are at risk of intra-abdominal hypertension and abdominal compartment syndrome from pre hospital, emergency, operating room and intensive care areas
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ttransducer technique | Experimental | Procedure: transducer techniquethe nurses will measure intraabdominal pressure at each shift during the day by using transducer technique |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all nurses that have more than one years experience in the trauma ,general and gastrointestinal ICU
Key exclusion criteria (1 listed)
- nurses less than one year experience
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 |
|---|---|---|
| transducer techniqueAlso: monitoring intraabdominal pressurethe nurses will receive the intervention ( the transducer method) to measure intraabdominal pressure intraabdominal hypertension and how to measure intraabdominal pressure in the third section | Procedure or surgery | ttransducer technique |
Primary outcome
improve nurses knowledge and practice about abdominal compartment syndrome
Time frame: 6 months
pretest and post questionaire will be used to evaluate the improvement in nurses knowledge and practice about abdominal compartment syndrome
1 secondary outcome
prevent abdominal compartment syndrome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 22873422Newcombe J, Mathur M, Bahjri K, Ejike JC. Pediatric critical care nurses' experience with abdominal compartment syndrome. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S6. doi: 10.1186/2110-5820-2-S1-S6. Epub 2012 Jul 5.
- Background: PubMed 24499574Hunt L, Frost SA, Hillman K, Newton PJ, Davidson PM. Management of intra-abdominal hypertension and abdominal compartment syndrome: a review. J Trauma Manag Outcomes. 2014 Feb 5;8(1):2. doi: 10.1186/1752-2897-8-2.
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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.
Ghada Sh Khalaf, Lecturer principal investigator
Assuit university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transducer technique in people with Intraabdominal Hypertension, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Dec 2015. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
improve nurses knowledge and practice about abdominal compartment syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639013, which also lists 2 linked publications.
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 24 Dec 2015.