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OpenTrials
Completed

NCT Number: NCT01457248

Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

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.

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Key information

Conditions

Postoperative Pneumonia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Tracheostomized patients

Treatment and study plan

Endotracheal tube TaperGuard

Device

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

Endotracheal tube Hi-Contour Brandt

Device

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

Primary outcomes

  1. Incidence of first episode of postoperative pneumonia after aortic surgery

    Time frame: Within the first 28 days after surgery

Secondary outcomes

  1. Microaspiration

    Time frame: Day 1 and day 2

  2. Length of ICU stay

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

  3. Mortality

    Time frame: Day 28 and day 90

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Registry information

Official study title

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

Acronym: TETRIS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2011
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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