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

Primary Purpose

Postoperative Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endotracheal tube TaperGuard
Endotracheal tube Hi-Contour Brandt
Sponsored by
Groupe Hospitalier Pitie-Salpetriere
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pneumonia focused on measuring after aortic surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Tracheostomized patients

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endotracheal tube with taper-shaped cuff

Endotracheal tube with cylindrical-shaped cuff

Arm Description

Outcomes

Primary Outcome Measures

Incidence of first episode of postoperative pneumonia after aortic surgery

Secondary Outcome Measures

Microaspiration
Length of ICU stay
Mortality

Full Information

First Posted
October 18, 2011
Last Updated
July 2, 2014
Sponsor
Groupe Hospitalier Pitie-Salpetriere
Collaborators
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
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1. Study Identification

Unique Protocol Identification Number
NCT01457248
Brief Title
Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections
Acronym
TETRIS
Official Title
Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere
Collaborators
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pneumonia
Keywords
after aortic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endotracheal tube with taper-shaped cuff
Arm Type
Experimental
Arm Title
Endotracheal tube with cylindrical-shaped cuff
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Endotracheal tube TaperGuard
Intervention Description
Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
Intervention Type
Device
Intervention Name(s)
Endotracheal tube Hi-Contour Brandt
Intervention Description
Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)
Primary Outcome Measure Information:
Title
Incidence of first episode of postoperative pneumonia after aortic surgery
Time Frame
Within the first 28 days after surgery
Secondary Outcome Measure Information:
Title
Microaspiration
Time Frame
Day 1 and day 2
Title
Length of ICU stay
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Title
Mortality
Time Frame
Day 28 and day 90

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 ans Elective aortic surgery Admission in ICU after aortic surgery Exclusion Criteria: Tracheostomized patients
Facility Information:
Facility Name
Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18007268
Citation
Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.
Results Reference
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PubMed Identifier
21836137
Citation
Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.
Results Reference
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PubMed Identifier
20682571
Citation
Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.
Results Reference
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PubMed Identifier
19557389
Citation
Hortal J, Giannella M, Perez MJ, Barrio JM, Desco M, Bouza E, Munoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.
Results Reference
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Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

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