Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Respiration, Artificial Clinical Trial

Official title:

Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170156
• Other study ID #: 2010REACHR01
• Secondary ID: 2010-A00539-30
• Status: Completed
• Phase: N/A
• First received: July 22, 2010
• Last updated: March 4, 2011
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Centre Hospitalier de Roanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Sedation
• Respiration, Artificial

Intervention

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.

Locations

Country	Name	City	State
France	CH de Roanne	Roanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Roanne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No