Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

Not Applicable

Completed

• Conditions: Postoperative Pneumonia

• Registration Number: NCT01457248
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

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

Exclusion Criteria

• Tracheostomized patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of first episode of postoperative pneumonia after aortic surgery	Within the first 28 days after surgery

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Microaspiration	Day 1 and day 2
Mortality	Day 28 and day 90

Trial Locations

Locations (1)

Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France