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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03946371
Recruitment Status : Unknown
Verified May 2019 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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

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
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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 26, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : September 1, 2021
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946371


Contacts
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Contact: Clément VILLARET +33789233860 clementvillaret@gmail.com
Contact: Jonathan PAILLOT +33650369959 jpaillot@chu-besancon.fr

Locations
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France
Chu Besancon Recruiting
Besancon, Doubs, France, 25000
Contact: Clément VILLARET    +33789233860    clementvillaret@gmail.com   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Jonathan Paillot, MD CHU Jean Minjoz
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03946371    
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

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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:
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Pneumonia, Bacterial
Pneumonia
Respiratory Tract Infections
Infections
 Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses