Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

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).

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial; Deep Sedation
• Intervention / Treatment: Device: Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Roanne, France, 42300
    • CH de Roanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Roanne
• Investigators: Principal Investigator: Pascal BEURET, MD, CH de Roanne

Publications and helpful links

General Publications

• Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (ESTIMATE): July 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 7, 2011
• Last Update Submitted That Met QC Criteria: March 4, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: deep sedation; respiratory resuscitation; Hi-Lo Evac tube; suctioning manoeuvre
• Other Study ID Numbers: 2010REACHR01; 2010-A00539-30 (OTHER: AFSSAPS)