Intraabdominal HypertensionGhadaNCT02644733
Effect of Different Body Position on Intraabdominal Pressure in Mechanically Ventilated Patients
An observational study of Intraabdominal Hypertension, run by Assiut University at 2 sites in Egypt.
Trial summary
Measuring intraabdominal pressure in the semi-recumbent position and supine position. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intraabdominal Hypertension
- What is being tested?
- head of bed elevation 30 degree and urinary catheter
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2016to May 2017
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult mechanically ventilated patients
Who may be able to join
- older than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place
Who cannot join
- recent oesophageal, gastric or bladder surgery; patients who were moribund and unlikely to survive 24 h; patients who were pregnant and patients who were unable to lay flat for any reason.
Trial locations and contacts
2 sites in 1 country.
Ghada Sh Khalaf, Lecturer contact
Sayed Ka Abd-elshaffy, professor contact
Egypt2 sites, 2 recruiting
- Recruiting
Assuit university hospital
Asyut, Assuit, 088
Ghada sh Khalaf, lecturer, 01062003314, ghadashalaby66@yahoo.com
Esam Ez Abd alhakiem
- Recruiting
Faculty of Nursing
Egypt, Assuit, 02
Ghada sh Khalaf, lecturer, 01062003314, ghadashalaby66@yahoo.com
Esam Ez Abd alhakiem, Prof
About this study
Official title: Lecturer in Critical Care Nursing Department
Measuring intraabdominal pressure in the semi-recumbent position and supine position.
Read the detailed description
Each set of measurements of intraabdominal pressure included intra bladder and intragastric pressure in the supine position followed by the semi-recumbent position at head of bed 30. All four measurements were taken over a period of 5 to 10 min or less to reduce the possibility of changes in intraabdominal pressure over time. Three sets of readings were taken at least 4 h apart over a 24-h period.
- Conditions
- Intraabdominal Hypertension
- Being tested
- head of bed elevation 30 degree, urinary catheter
- 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.
head of bed elevation 30 degreeProcedure or surgery
Also called HOB30
the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree
urinary catheterProcedure or surgery
Also called flat position
the intraabdominal pressure will be measured by urinary catheter when the patient in supine position
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the effect of different body position on the intraabdominal pressure
the intraabdominal pressure will be measured by urinary catheter and nasogastric tube when the patient in semi-recumbent position at 30 head of bed elevation)
Measured: up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT02644733
- Sponsor's protocol ID
- Ghada22
- Acronym
- Ghada
- Status last verified
- Feb 2017
- First submitted
- 27 Dec 2015
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: the patient's assessment sheet will be used to collect the data by the researcher
Publications
Rooban N, Regli A, Davis WA, De Keulenaer BL. Comparing intra-abdominal pressures in different body positions via a urinary catheter and nasogastric tube: a pilot study. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S11. doi: 10.1186/2110-5820-2-S1-S11. Epub 2012 Jul 5.
PubMed 22873412
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer in Critical Care Nursing Department
- ClinicalTrials.gov ID
- NCT02644733
- Acronym / sponsor ID
- Ghada / Ghada22
- Conditions
- Intraabdominal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Jan 2016 (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.
Measuring intraabdominal pressure in the semi-recumbent position and supine position.
Detailed description
Each set of measurements of intraabdominal pressure included intra bladder and intragastric pressure in the supine position followed by the semi-recumbent position at head of bed 30. All four measurements were taken over a period of 5 to 10 min or less to reduce the possibility of changes in intraabdominal pressure over time. Three sets of readings were taken at least 4 h apart over a 24-h period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult mechanically ventilated patients
Key inclusion criteria (1 listed)
- older than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place
Key exclusion criteria (1 listed)
- recent oesophageal, gastric or bladder surgery; patients who were moribund and unlikely to survive 24 h; patients who were pregnant and patients who were unable to lay flat for any reason.
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 |
|---|---|---|
| head of bed elevation 30 degreeAlso: HOB30the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree | Procedure or surgery | – |
| urinary catheterAlso: flat positionthe intraabdominal pressure will be measured by urinary catheter when the patient in supine position | Procedure or surgery | – |
Primary outcome
determine the effect of different body position on the intraabdominal pressure
Time frame: up to 24 hour
the intraabdominal pressure will be measured by urinary catheter and nasogastric tube when the patient in semi-recumbent position at 30 head of bed elevation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 22873412Rooban N, Regli A, Davis WA, De Keulenaer BL. Comparing intra-abdominal pressures in different body positions via a urinary catheter and nasogastric tube: a pilot study. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S11. doi: 10.1186/2110-5820-2-S1-S11. Epub 2012 Jul 5.
- Individual participant dataSharing planned: Yes. the patient's assessment sheet will be used to collect the data by the researcher
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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 contact
Sayed Ka Abd-elshaffy, professor contact
Ghada Sh Khalaf, Lecturer principal investigator
Assuit university hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Hypertension, run by Assiut University at 2 sites 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Ghada Sh Khalaf, Lecturer (ghadashalaby66@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the effect of different body position on the intraabdominal pressure (time frame: up to 24 hour). 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 NCT02644733, which also lists 1 linked publication.
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 8 Feb 2017.