Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

NCT ID: NCT01170156

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-01-31

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.

Conditions

Deep Sedation; Respiration, Artificial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Hi-Lo Evac tube (Mallinckrodt Inc, USA); Blue dye 2.5% (Guerbet, France)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Roanne

OTHER

Sponsor Role: lead

Responsible Party

CH de Roanne

Principal Investigators

Pascal BEURET, MD

Role: PRINCIPAL_INVESTIGATOR

CH de Roanne

Locations

CH de Roanne

Roanne, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23134813 (View on PubMed)

Other Identifiers

2010-A00539-30

Identifier Type: OTHER

Identifier Source: secondary_id

2010REACHR01

Identifier Type: -

Identifier Source: org_study_id