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Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111578
First Posted: April 27, 2010
Last Update Posted: November 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Policlinico Hospital
  Purpose
Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric pressure of a new enteral feeding tube

Condition Intervention
Respiratory Failure Device: Enteral feeding tube

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Accuracy of the measurement of the esophageal and gastric pressure [ Time Frame: 1 hour ]

Estimated Enrollment: 30
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
New enteral feeding tube Device: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Requiring the placement of an enteral feeding tube

Exclusion Criteria:

  • esophageal ulcers
  • severe coagulophaty
  • thrombocytopenia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111578


Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, MI, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Fondazione IRRCS Ca' Granda Ospedale Maggiore Policlinico
  More Information

Responsible Party: Davide Chiumello, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01111578     History of Changes
Other Study ID Numbers: 17610
First Submitted: April 12, 2010
First Posted: April 27, 2010
Last Update Posted: November 30, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases