Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

NCT ID: NCT01457248

Last Updated: 2014-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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endotracheal tube with taper-shaped cuff

Group Type EXPERIMENTAL

Endotracheal tube TaperGuard

Intervention Type DEVICE

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

Endotracheal tube with cylindrical-shaped cuff

Group Type ACTIVE_COMPARATOR

Endotracheal tube Hi-Contour Brandt

Intervention Type DEVICE

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

Interventions

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Endotracheal tube TaperGuard

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

Intervention Type DEVICE

Endotracheal tube Hi-Contour Brandt

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Tracheostomized patients
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Qin Lu

Head of clinical research unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 18007268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21836137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20682571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19557389 (View on PubMed)

Other Identifiers

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2011-A01038-33

Identifier Type: OTHER

Identifier Source: secondary_id

HMGS-2011-1

Identifier Type: -

Identifier Source: org_study_id

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