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
-
-
-
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
|
Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
|
|
Active Comparator: Endotracheal tube with cylindrical-shaped cuff
|
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.
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
- 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.
- 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.
- 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.
- 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.
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.