Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

Postoperative Pneumonia Clinical Trial

— TETRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457248
• Other study ID #: HMGS-2011-1
• Secondary ID: 2011-A01038-33
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: July 2, 2014
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age = 18 ans

• Elective aortic surgery

• Admission in ICU after aortic surgery

Exclusion Criteria:

• Tracheostomized patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Postoperative Pneumonia

Intervention

Device:
• Endotracheal tube TaperGuard
Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
• Endotracheal tube Hi-Contour Brandt
Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)

Locations

Country	Name	City	State
France	Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

Hortal J, Giannella M, Pérez MJ, Barrio JM, Desco M, Bouza E, Muñoz 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of first episode of postoperative pneumonia after aortic surgery		Within the first 28 days after surgery	No
Secondary	Microaspiration		Day 1 and day 2	No
Secondary	Length of ICU stay		Participants will be followed for the duration of ICU stay, an expected average of 3 weeks	No
Secondary	Mortality		Day 28 and day 90	No