Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Study Overview
=================
Brief Summary
-----------------
The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

Detailed Description
-----------------
This clinical study aims to confirm these experimental data in patients under mechanical ventilation.

Official Title
-----------------
Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Conditions
-----------------
Deep Sedation, Respiration, Artificial

Intervention / Treatment
-----------------
* Device: Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated with a Hi-Lo Evac tube since less than 48 hours under continuous sedation written consent signed Exclusion Criteria: hemodynamic instability allergy of blue dye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)|The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre. | The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi. | 48 hours after the beginning of the mechanical ventilation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep sedation, respiratory resuscitation, Hi-Lo Evac tube, suctioning manoeuvre