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Clinical Trials/NCT02450669
NCT02450669CompletedNot Applicable

Practices and Risk Factors for Weaning and Extubation Airway Failure in Adult Intensive Care Unit: a Multicenter Trial

University Hospital, Montpellier1 site in 1 country417 target enrollmentStarted: December 19, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
417
Locations
1
Primary Endpoint
Risk factors of airway failure (logistic regression will be used to identify risk factors)

Study Overview

Brief Summary

Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of extubation has to be daily assessed in intubated patients.

The investigators aimed to assess incidence and risk factors of airway failure after extubation procedure in critically ill patients in a prospective multicenter study.

Detailed Description

Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of extubation has to be daily assessed in intubated patients. If the patient stay intubated too long, complications of prolonged mechanical ventilation may appear. If the patient is extubated too early, reintubation is associated with higher morbidity and mortality. "Airway failure", defined as the inability to breathe without endotracheal tube, differs from "weaning failure", defined as the inability to breathe spontaneously without invasive mechanical ventilation. "Mixed failure" occurs when extubation failure is caused by both airway and weaning failure. However, most of the studies assessing criteria of success of extubation did not separate airway from weaning success.

Study design and population A prospective, observational, multicenter study will be conducted in ICUs to develop a predictive model for airway failure following extubation. All adult patients consecutively intubated in ICU will be included. Exclusion criteria are pregnancy, refusal to participate after information was provided or age under 18 years old.

Ethics and consent Because of the observational, non invasive design of this study, the need for written consent is waived. The local ethics committee "Comité de Protection des personnes Sud-Mediterranée III" approved the study design (code UF: 9242, register: 2013-A01402-43).

Data collection Clinical parameters will be prospectively assessed before, during and after extubation procedure. In summary, the following data will be assessed before extubation : demographic data, body mass index (BMI), severity scores (Simplified Acute Physiologic Score (SAPS) II at admission, Sequential Organ Failure Assessment (SOFA) score on the day of the procedure), type of admission (medical vs surgical), co morbidities such as ethylism, smoking, cirrhosis, chronic obstructive pulmonary disease (COPD), cause of admission, cause and location of initial intubation, hypotension episode during the stay, difficulty of intubation, material used for intubation, Mallampati score, Cormack score, date and hour of extubation, a previous intubation in the last two weeks. Will be also assessed before extubation the type of spontaneous breathing trial (SBT), the use of a weaning mode before extubation, standard analysis, physiotherapy measurements, the assessment of agitation and answer to simple orders, the strength of cough, the perception of the extubation by the patient, a leak test before extubation, the blood results at the end of the SBTs, the succion rate and secretions aspect, the use of systemic corticotherapy before extubation.

Just before and during the extubation, sequential organ failure assessment (SOFA) score will be assessed, as the information of the patient, the nature and number of the operators, preoxygenation before extubation, precautions used in case of extubation failure.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patient extubated in the ICU

Exclusion Criteria

  • Decision not to reintubate

Outcomes

Primary Outcomes

Risk factors of airway failure (logistic regression will be used to identify risk factors)

Time Frame: 48 hours

Secondary Outcomes

  • Risf factors of extubation failure and weaning failure (Quantitative variables will be expressed as means (standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or the Wilcoxon test as appropriate(48 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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