Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier de Roanne
ClinicalTrials.gov Identifier:
NCT01170156
First received: July 22, 2010
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention
Deep Sedation
Respiration, Artificial
Device: Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Further study details as provided by Centre Hospitalier de Roanne:

Primary Outcome Measures:
  • Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre. [ Time Frame: 48 hours after the beginning of the mechanical ventilation ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Hi-Lo Evac tube (Mallinckrodt Inc, USA)
    • Blue dye 2.5% (Guerbet, France)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170156

Locations
France
CH de Roanne
Roanne, France, 42300
Sponsors and Collaborators
Centre Hospitalier de Roanne
Investigators
Principal Investigator: Pascal BEURET, MD CH de Roanne
  More Information

No publications provided

Responsible Party: Véronique BOURRACHAUT, CH de Roanne
ClinicalTrials.gov Identifier: NCT01170156     History of Changes
Other Study ID Numbers: 2010REACHR01, 2010-A00539-30
Study First Received: July 22, 2010
Last Updated: March 4, 2011
Health Authority: France: French Data Protection Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier de Roanne:
deep sedation
respiratory resuscitation
Hi-Lo Evac tube
suctioning manoeuvre

ClinicalTrials.gov processed this record on September 22, 2014