Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections (TETRIS)

July 2, 2014 updated by: Qin Lu, Groupe Hospitalier Pitie-Salpetriere

Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery

The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

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

  • France
      • Paris, France, 75013
        • Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 ans
  • Elective aortic surgery
  • Admission in ICU after aortic surgery

Exclusion Criteria:

  • Tracheostomized patients

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endotracheal tube with taper-shaped cuff
Device: Endotracheal tube TaperGuard
Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
Active Comparator: Endotracheal tube with cylindrical-shaped cuff
Device: Endotracheal tube Hi-Contour Brandt
Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of first episode of postoperative pneumonia after aortic surgery
Time Frame: Within the first 28 days after surgery
Within the first 28 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Microaspiration
Time Frame: Day 1 and day 2
Day 1 and day 2
Length of ICU stay
Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Mortality
Time Frame: Day 28 and day 90
Day 28 and day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMGS-2011-1
  • 2011-A01038-33 (Other Identifier: Afssaps)

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.

Clinical Trials on Postoperative Pneumonia

Clinical Trials on Endotracheal tube TaperGuard

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe