NCT01555229

Brief Summary

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

April 1, 2015

Enrollment Period

4.1 years

First QC Date

July 1, 2011

Last Update Submit

September 16, 2015

Conditions

Mechanical Ventilation Complication

Keywords

Secretion drainageVentilator-associated pneumoniaTracheal fibroscopy

Outcome Measures

Primary Outcomes (1)

  • Tracheal mucosal damages assessed by tracheal fibroscopy.

    * stage 0: no lesion * stage 1: erythema * stage 2 : oedema * stage 3 : ulceration * stage 4 : necrosis

    the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)

Secondary Outcomes (3)

  • Volume of daily secretions

    During intubation

  • Occurrence of difficulties or impossibilities of secretion drainage

    During intubation

  • Occurrence of ventilator-associated pneumonia

    During intubation

Study Arms (2)

Intermittent drainage

EXPERIMENTAL

Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.

Device: Intermittent subglottic secretion drainage

Continuous drainage.

ACTIVE COMPARATOR

Continuous subglottic secretion drainage at -20 mmHg.

Device: Continuous subglottic secretion drainage

Interventions

Intermittent subglottic secretion drainageDEVICE

Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.

Intermittent drainage
Continuous subglottic secretion drainageDEVICE

Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.

Continuous drainage.

Eligibility Criteria

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

You may qualify if:

  • Adult aged 18 years or more
  • Patients hospitalized in intensive care unit
  • Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours

You may not qualify if:

  • Pregnant or breast-feeding women
  • Previous known tracheal lesions
  • Persons deprived of freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Chirurgicale, Hôpital de Pontchaillou

Rennes, 35033, France

Location

Related Publications (1)

  • Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.

    PMID: 29422724DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Laviolle, MD, PhD

    Rennes University Hospital

    STUDY CHAIR

  • Philippe Seguin, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

March 15, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-04

Locations

FR(1)