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

Pneumonia, Bacterial Clinical Trial

— SEGEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03946371
• Other study ID #: P/2019/429
• Status: Recruiting
• Start date: April 26, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Clément VILLARET
• Phone: +33789233860
• Email: clementvillaret[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Extubation
• Aspiration of Subglottic Secretions
• Pneumonia
• Pneumonia, Bacterial

Locations

Country	Name	City	State
France	Chu Besancon	Besancon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation failure	defined as a need for reintubation within 48 h after extubation	48 hours
Primary	Volume of Subglottic Secretion	Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical	24 weeks
Secondary	Weaning mechanical ventilation failure	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)	7 days
Secondary	Pneumonia post extubation	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	7 days
Secondary	Length of stay in ICU	Length of stay in ICU	22 month
Secondary	Mortality	Death	28 days