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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457248
First Posted: October 21, 2011
Last Update Posted: July 3, 2014
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.
Collaborator:
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
Information provided by (Responsible Party):
Qin Lu, Groupe Hospitalier Pitie-Salpetriere
  Purpose
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.

Condition Intervention
Postoperative Pneumonia Device: Endotracheal tube TaperGuard Device: Endotracheal tube Hi-Contour Brandt

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery

Resource links provided by NLM:


Further study details as provided by Qin Lu, Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • Incidence of first episode of postoperative pneumonia after aortic surgery [ Time Frame: Within the first 28 days after surgery ]

Secondary Outcome Measures:
  • Microaspiration [ Time Frame: 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 ]
  • Mortality [ Time Frame: Day 28 and day 90 ]

Enrollment: 162
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Tracheostomized patients
  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): NCT01457248


Locations
France
Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
  More Information

Publications:
Responsible Party: Qin Lu, Head of clinical research unit, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT01457248     History of Changes
Other Study ID Numbers: HMGS-2011-1
2011-A01038-33 ( Other Identifier: Afssaps )
First Submitted: October 18, 2011
First Posted: October 21, 2011
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Qin Lu, Groupe Hospitalier Pitie-Salpetriere:
after aortic surgery

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections