Extubation Failure in Critically Ill Cirrhotic Patients.

NCT05244005 | Unknown

• 1 other identifier: RECHMPL21_0731
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Although a life-saving intervention, invasive mechanical ventilation (MV) prone to complications and side effects. Cirrhotic patients with a need of prolonged MV have a poor prognosis in ICU compared to general population of critically ill patients. The optimal time for weaning from MV and extubation is therefore a crucial objective. Extubation failure is defined as the need for reintubation within 48-72 hours (early). This time frame is sometimes extended to 7 days (delayed), especially when noninvasive ventilation is used during extubation (SFAR-SRLF 2018 recommendations). Some studies have investigated the risk factors for extubation failure in general population of critically ill patients, and in some specific subpopulations (COPD, brain injury, elderly). But little is known about extubation failure in cirrhotic patients admitted in ICU. The aim of the present study is to describe the incidence and identify specific risk factors for extubation failure in cirrhotic critically ill patients. Ultrasound and clinical data will be collected and analysed during the ICU stay.

Conditions

Cirrhosis; Mechanical Ventilation Complication; Critical Illness

Keywords

Extubation failure; Mechanical ventilation; Risk factors

Outcome Measures

Primary Outcomes (1)

• Incidence of extubation failure

  Incidence of extubation failure in cirrhotic patients ventilated for more than 6 hours in the ICU

  From extubation (day 0) to day 7 after extubation

Secondary Outcomes (1)

• Risk factors for extubation failure

  From extubation (day 0) to day 7 after extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive critically ill patients admitted to the intensive care unit of Saint Eloi University teaching hospital with a history or diagnosis of cirrhosis and requiring invasive mechanical ventilation for more than 6 hours.

You may qualify if:

• Adult patients
• Known history of cirrhosis or diagnosis of cirrhosis during the ICU stay
• Invasive mechanical ventilation for more than 6 hours
• Eligible for extubation according to the physician in charge

You may not qualify if:

• Pregnancy,
• Age below 18
• Terminal extubation
• Absence of consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Fibrosis; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Yassir AARAB

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yassir AARAB, MD

CONTACT

467337271; y-aarab@chu-montpellier.fr

Albert PRADES

CONTACT

-prades@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 17, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 31, 2023
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

FR (1)