NCT01111578

Brief Summary

Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric pressure of a new enteral feeding tube

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 30, 2010

Status Verified

April 1, 2010

Enrollment Period

10 months

First QC Date

April 12, 2010

Last Update Submit

November 29, 2010

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the measurement of the esophageal and gastric pressure

    1 hour

Study Arms (1)

New enteral feeding tube

Device: Enteral feeding tube

Interventions

Enteral feeding tubeDEVICE

The esophageal and gastric pressure, measured with this new device, will be recorded and compared with those ones measured with a standard esophageal catheter

New enteral feeding tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Requiring the placement of an enteral feeding tube

You may not qualify if:

  • esophageal ulcers
  • severe coagulophaty
  • thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Davide Chiumello, MD

    Fondazione IRRCS Ca' Granda Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 27, 2010

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 30, 2010

Record last verified: 2010-04

Locations

IT(1)