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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:
Information provided by:
Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01111578
First received: April 12, 2010
Last updated: November 29, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Davide Chiumello, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01111578     History of Changes
Other Study ID Numbers: 17610
Study First Received: April 12, 2010
Last Updated: November 29, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on November 27, 2014