Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03946371
Study type Observational
Source Centre Hospitalier Universitaire de Besancon
Contact Clément VILLARET
Phone +33789233860
Email clementvillaret@gmail.com
Status Recruiting
Phase
Start date April 26, 2019
Completion date September 1, 2021

See also
  Status Clinical Trial Phase
Completed NCT03303976 - Phase I to Test a New Pneumococcal Vaccine Phase 1
Completed NCT02459158 - A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia Phase 1
Recruiting NCT06113432 - CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study N/A
Active, not recruiting NCT03577964 - Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
Completed NCT04540081 - Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer N/A
Completed NCT00538694 - Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Phase 3
Withdrawn NCT02218359 - Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization Phase 2
Completed NCT01189487 - The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) Phase 3
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Withdrawn NCT00245453 - Outpatient Registry Trial of Respiratory Tract Infections in Adults Phase 4
Completed NCT03239665 - Vaccination Education Through Pharmacists and Senior Centers (VEPSC) N/A
Completed NCT03034642 - Modulation of Steroid Immunosuppression by Alveolar Efferocytosis N/A
Completed NCT04047719 - Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
Completed NCT02292498 - Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections N/A
Completed NCT01763008 - A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections Phase 4
Recruiting NCT05976581 - Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients N/A
Completed NCT03551210 - Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia Phase 3
Completed NCT04158804 - PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT N/A
Completed NCT00805168 - Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia Phase 3
Completed NCT02778672 - Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia N/A