- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111578
Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure
November 29, 2010 updated by: Policlinico Hospital
Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric pressure of a new enteral feeding tube
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MI
-
Milano, MI, Italy, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients admitted to a general and post-operative intensive care unit and who, for clinical reasons, need the placement of an enteral feeding tube
Description
Inclusion Criteria:
- Requiring the placement of an enteral feeding tube
Exclusion Criteria:
- esophageal ulcers
- severe coagulophaty
- thrombocytopenia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
New enteral feeding tube
|
The esophageal and gastric pressure, measured with this new device, will be recorded and compared with those ones measured with a standard esophageal catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accuracy of the measurement of the esophageal and gastric pressure
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Davide Chiumello, MD, Fondazione IRRCS Ca' Granda Ospedale Maggiore Policlinico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
April 12, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Estimate)
November 30, 2010
Last Update Submitted That Met QC Criteria
November 29, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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