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

This study has been completed.
Sponsor:
Collaborator:
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
Information provided by (Responsible Party):
Qin Lu, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT01457248
First received: October 18, 2011
Last updated: July 2, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microaspiration [ Time Frame: Day 1 and day 2 ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Day 28 and day 90 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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: 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
Study First Received: October 18, 2011
Last Updated: July 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 20, 2014