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Completed

NCT Number: NCT01170156

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Roanne

Roanne, 42300, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)

Device

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)

Primary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Roanne

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2010
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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