NCT02644733

Brief Summary

Measuring intraabdominal pressure in the semi-recumbent position and supine position.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

December 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

December 27, 2015

Last Update Submit

February 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    up to 24 hour

Interventions

the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree

Also known as: HOB30

the intraabdominal pressure will be measured by urinary catheter when the patient in supine position

Also known as: flat position

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

adult mechanically ventilated patients

You may qualify if:

  • older than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assuit university hospital

Asyut, Assuit, 088, Egypt

RECRUITING

Faculty of Nursing

Egypt, Assuit, 02, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22873412BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Ghada Sh Khalaf, Lecturer

    Assuit university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada Sh Khalaf, Lecturer

CONTACT

Sayed Ka Abd-elshaffy, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in critical care nursing department

Study Record Dates

First Submitted

December 27, 2015

First Posted

January 1, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

the patient's assessment sheet will be used to collect the data by the researcher

Locations