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.

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

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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