NCT01170156

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

July 22, 2010

Last Update Submit

March 4, 2011

Conditions

Deep SedationRespiration, Artificial

Keywords

deep sedationrespiratory resuscitationHi-Lo Evac tubesuctioning manoeuvre

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Also known as: Hi-Lo Evac tube (Mallinckrodt Inc, USA), Blue dye 2.5% (Guerbet, France)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intubated with a Hi-Lo Evac tube since less than 48 hours
  • under continuous sedation
  • written consent signed

You may not qualify if:

  • hemodynamic instability
  • allergy of blue dye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Roanne

Roanne, 42300, France

Location

Related Publications (1)

  • 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.

    PMID: 23134813DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pascal BEURET, MD

    CH de Roanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 27, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

FR(1)