NCT01807884

Brief Summary

The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

January 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 12, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2016

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

January 30, 2013

Last Update Submit

July 10, 2017

Conditions

Ventilator Acquired PneumoniaAspiration

Keywords

MicroaspirationVentilator acquired PneumoniaAmylaseMechanical ventilationSuction

Outcome Measures

Primary Outcomes (1)

  • tracheal to oropharyngeal ratio of amylase enzymatic activity

    As a surrogate for microaspiration, the tracheal to oropharyngeal ratio of amylase enzymatic activity will be assessed after oral care. A mean of measures realized one day after optimized oral care will be compared to a mean of measure realized the other day after standard oral care as a cross over protocol.

    Day 1 and Day 2

Secondary Outcomes (3)

  • volume of the tracheal, subglottic, and oral suctions

    three time a day, during 2 days

  • length of each mouth care

    three time a day, during 2 days

  • cost of the optimized oral suctioning compared with routine care

    At the end of the period of study (48hours) for each patient

Study Arms (2)

Optimized oral care

EXPERIMENTAL

An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction

Procedure: Optimized oral care

Routine oral care

PLACEBO COMPARATOR

Oral suction followed by mouth care and tracheal suction

Other: Routine oral care

Interventions

Optimized oral carePROCEDURE

An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction

Optimized oral care
Routine oral careOTHER

Oral suction followed by mouth care and tracheal suction without any subglottic suction

Routine oral care

Eligibility Criteria

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

You may qualify if:

  • Intubated with a subglottic secretion drainage device
  • ventilated more than 48 hours
  • patients yielding a significant tracheal suctioning volume (on a semi-qualitative evaluation: ≥ ++ on a scale consisting of 0,+,++,+++)

You may not qualify if:

  • paralysed patients
  • patients with Ramsay 1, 2
  • patients breathing spontaneously
  • patients less than 18 years old
  • patients in a moribund state
  • contra-indication for suctioning procedure (risk of haemorrhage, bronchospasm, Acute Respiratory Distress Syndrome with P/F \< 100, malformation or tracheal fistula)
  • bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease
  • patients necessitating a closed-suctioning device (prevention of respiratory multiresistant bacteria transmission, Acute Respiratory Distress Syndrome with P/F ratio \< 100)
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pellegrin

Bordeaux, Gironde, 33000, France

Location

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

  • Alexandre Boyer, MD

    Université Victor Segalen Bordeaux 2

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Marion Griton, MD

Study Record Dates

First Submitted

January 30, 2013

First Posted

March 8, 2013

Study Start

November 12, 2014

Primary Completion

March 4, 2016

Study Completion

March 4, 2016

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)