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

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

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

Study Overview

• Status: Unknown
• Conditions: Pneumonia, Bacterial; Airway Extubation; 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Clément VILLARET; Phone Number: +33789233860; Email: clementvillaret@gmail.com
• Study Contact Backup: Name: Jonathan PAILLOT; Phone Number: +33650369959; Email: jpaillot@chu-besancon.fr

Study Locations

• France
  • Doubs
    • Besancon, Doubs, France, 25000
      • Recruiting
      • CHU Besançon
      • Contact: Clément VILLARET; Phone Number: +33789233860; Email: clementvillaret@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length of stay in ICU	Length of stay in ICU	22 month
Mortality	Death	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Jonathan Paillot, MD, CHU Jean Minjoz

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Sub glottic secretions; Failure Extubation; endotracheal tube
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial
• Other Study ID Numbers: P/2019/429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No