NCT01457248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

October 18, 2011

Last Update Submit

July 2, 2014

Conditions

Postoperative Pneumonia

Keywords

after aortic surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of first episode of postoperative pneumonia after aortic surgery

    Within the first 28 days after surgery

Secondary Outcomes (3)

  • Microaspiration

    Day 1 and day 2

  • Length of ICU stay

    Participants will be followed for the duration of ICU stay, an expected average of 3 weeks

  • Mortality

    Day 28 and day 90

Study Arms (2)

endotracheal tube with taper-shaped cuff

EXPERIMENTAL
Device: Endotracheal tube TaperGuard

Endotracheal tube with cylindrical-shaped cuff

ACTIVE COMPARATOR
Device: Endotracheal tube Hi-Contour Brandt

Interventions

Endotracheal tube TaperGuardDEVICE

Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)

endotracheal tube with taper-shaped cuff
Endotracheal tube Hi-Contour BrandtDEVICE

Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)

Endotracheal tube with cylindrical-shaped cuff

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Tracheostomized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

Related Publications (4)

  • 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.

    PMID: 18007268BACKGROUND

  • 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.

    PMID: 21836137BACKGROUND

  • 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.

    PMID: 20682571BACKGROUND

  • 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.

    PMID: 19557389BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical research unit

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

FR(1)