NCT03946371

Brief Summary

This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 24, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

April 24, 2019

Last Update Submit

May 9, 2019

Conditions

Airway ExtubationPneumonia, BacterialAspiration of Subglottic Secretions

Keywords

Sub glottic secretionsFailure Extubationendotracheal tube

Outcome Measures

Primary Outcomes (2)

  • Extubation failure

    defined as a need for reintubation within 48 h after extubation

    48 hours

  • Volume of Subglottic Secretion

    Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical

    24 weeks

Secondary Outcomes (4)

  • Weaning mechanical ventilation failure

    7 days

  • Pneumonia post extubation

    7 days

  • Length of stay in ICU

    22 month

  • Mortality

    28 days

Study Arms (2)

Extubation Success

Patients who do not require re-intubation, upto 48 hours after a planned extubation in the adult intensive care unit.

Extubation failure

Patients who required re-intubation within 48 hours after a planned extubation in adult intensive care unit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted in intensive care intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours; and receiving mechanical ventilation for more than 48 hours. Planned extubations in the intensive care

You may qualify if:

  • intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours
  • mechanical ventilation for more than 48 hours
  • planned extubations in the intensive care

You may not qualify if:

  • age \< 18 years
  • terminal extubation
  • Self extubation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Besancon

Besançon, Doubs, 25000, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jonathan Paillot, MD

    CHU Jean Minjoz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément VILLARET

CONTACT

+33789233860clementvillaret@gmail.com

Jonathan PAILLOT

CONTACT

+33650369959jpaillot@chu-besancon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 10, 2019

Study Start

April 26, 2019

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations

FR(1)