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Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages

NCT01555229 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-09-17

No results posted yet for this study

Summary

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

Conditions

  • Mechanical Ventilation Complication

Interventions

DEVICE

Intermittent subglottic secretion drainage

Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.

DEVICE

Continuous subglottic secretion drainage

Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno Laviolle, MD, PhD · Rennes University Hospital

  • Philippe Seguin, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555229 on ClinicalTrials.gov