Clinical trial NCT03946371: Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients (SEGEX)
Official title: Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Extubation
Pneumonia, Bacterial
Aspiration of Subglottic Secretions
Keywords: Sub glottic secretions
Failure Extubation
endotracheal tube
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility 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

Primary outcomes:
measure: Extubation failure
timeFrame: 48 hours
measure: Volume of Subglottic Secretion
timeFrame: 24 weeks
Secondary outcomes:
measure: Weaning mechanical ventilation failure
timeFrame: 7 days
measure: Pneumonia post extubation
timeFrame: 7 days
measure: Length of stay in ICU
timeFrame: 22 month
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chu Besancon
state: Doubs
Study officials:
affiliation: CHU Jean Minjoz
name: Jonathan Paillot, MD
role: PRINCIPAL_INVESTIGATOR
References: