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Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients (SEGEX)

  • Clinicaltrials.gov identifier

    NCT03946371

  • Recruitment Status

    Recruiting

  • First Posted

    May 10, 2019

  • Last update posted

    May 10, 2019

Study Description

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.

  • Condition or Disease:Airway Extubation
    Pneumonia, Bacterial
    Aspiration of Subglottic Secretions
  • Intervention/Treatment:
  • Phase: N/A

Detailed Description

Between 10 and 20% of patients develop extubation failure (10.7% in our ICU at 2018), which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. Tracheal secretions, LVEF<30%, MV > 7d, Weak of cough are identified as risk factors of extubation failures but are not completely performants. Avoiding reintubation remains an important clinical goal. The subglottic secretion drainage above the cuff of an endotracheal tube is recognized as an effective method to prevent ventilator-associated pneumonia (VAP) in critically ill patients. The subglottic secretion drainage is used in a regular way in our ICU. Volume of subglottic secretion is not analysed in the scientific literature. Study : The investigators hypothesize that high volume of subglottic secretion before extubation is associated with high risk of extubation failure and à high risk of pneumonia post extubation. All planned extubations in the intensive care unit after 2 days minimal of mechanic ventilation are recorded on a designated form and standard variables charted. All data will be collected retrospectively after the extubation event. All included patients will be assigned a unique identification number (UID) by the investigator, who will secure the patient identifiers in an encrypted electronic file. The cause of extubation failure will be recorded (as identified by the attending physician on service, who is not involved in the study). For statistical analysis, group that fail extubation, will be compared, with the group that was an extubation success. Standard demographics (age, sex), patient disease related factors (diagnosis, duration of intubation, secretions), care factors (cuff leak test, p/f ratio prior to extubation,LVEF<30% ), and post extubation care (post extubation respiratory support, stridor, blood gas, pneumonia) along with any complication during extubation and reintubation and reasons for reintubation will be collected and compared. As two groups are being compared, bivariate analyses utilizing Chi-square tests or univariate logistic regression for categorical variables and Student t -tests for interval variables, will be done. Investigators will perform an interim analysis at the end of 12 months and a final analysis

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 300 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: September 2021

Outcome Measures

  • Primary Outcome Measures: 1. Extubation failure [ Time Frame: 48 hours ]
    defined as a need for reintubation within 48 h after extubation
  • 2. Volume of Subglottic Secretion [ Time Frame: 24 weeks ]
    Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical
  • Secondary Outcome Measures: 1. Weaning mechanical ventilation failure [ Time Frame: 7 days ]
    Use of non-invasive ventilation ( non-invasive ventilation / High-Flow Nasal Cannula) for curative purposes within 7 days after extubation or failure extubate within 72 hours (7 days if using NIV-HFNC)
  • 2. Pneumonia post extubation [ Time Frame: 7 days ]
    If diagnosis retained by the doctor in charge of the patient and antibiotherapy set up for a duration of more than 5 days and occurred within 7 days post extubation
  • 3. Length of stay in ICU [ Time Frame: 22 month ]
    Length of stay in ICU
  • 4. Mortality [ Time Frame: 28 days ]
    Death

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability 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

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- age < 18 years - terminal extubation - Self extubation - Pregnancy

Contacts and Locations

Contacts

Contact: Clément VILLARET +33789233860 clementvillaret@gmail.com

Contact: Jonathan PAILLOT +33650369959 jpaillot@chu-besancon.fr

Locations

France, Doubs
Chu Besancon
Besancon

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Jonathan Paillot, MD CHU Jean Minjoz

More Information

  • Responsible Party: Centre Hospitalier Universitaire de Besancon
  • ClinicalTrials.gov Identifier: NCT03946371 History of Changes
  • Other Study ID Numbers: P/2019/429
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Hospitalier Universitaire de Besancon: Sub glottic secretions
    Failure Extubation
    endotracheal tube
  • Additional relevant MeSH terms: Pneumonia, Bacterial Pneumonia