Intubation in Intensive Care Units Clinical Trial
Official title:
Practices and Risk Factors for Weaning and Extubation Airway Failure in Adult Intensive Care Unit: a Multicenter Trial
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.
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.
Just after extubation, will be assessed physiotherapy after extubation, aerosols of
corticoids or adrenalins post extubation, and the occurrence in the hour after extubation of
complications. At 48 hours post extubation, the occurrence of reintubation will be
evaluated, and its relation with airway failure, weaning failure, or both (mixed failure).
In case of reintubation, the delay between extubation and reintubation will be informed, and
the cause of reintubation. Finally, at ICU discharge, the mortality will be analyzed, the
occurrence of late reintubation (>48h), the use and the length of mechanical or non invasive
ventilation, the need for vasopressors or dialysis after extubation, the occurrence of a
nosocomial pneumonia, a catheter infection, a bacteremia, a urinary infection. At the exit
of the hospital, the mortality at day 28 following extubation will be assessed.
Definition of extubation failure, airway failure, weaning failure, mixed failure and
complications Extubation failure is defined as the need to reintubate less than 48 hours
after extubation. The need to reintubate was left to the physician appreciation in this
observational study. Airway failure is defined as an extubation failure because of the
inability to breathe without a tracheal tube. Weaning failure is defined as an extubation
failure because of the inability to breathe without an invasive mechanical ventilation.
Mixed failure is a combination of airway and weaning failure. Severe life-threatening
complications are defined as death, cardiac arrest, severe cardiovascular collapse, defined
as systolic blood pressure<65 mmHg recorded at least one time and/or <90 mmHg that lasted
30min despite 500-1,000 ml of fluid loading (crystalloids/or colloids solutions) and/or
requiring introduction of vasoactive support, or severe hypoxemia (decrease in SpO2 below
80% during attempts), occurring during the first hour following intubation.
Outcomes The primary outcome are the risk factors for airway failure following extubation.
The secondary outcomes are the risk factors of extubation failure, weaning failure and mixed
failure, the incidence of extubation failure, airway failure, weaning failure and mixed
failure, the severe life-threatening complications related to extubation in ICU, the
moderate complications related to extubation in ICU, the rate of difficult intubation in
case of extubation failure.
Statistical analysis 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 (Gaussian or non Gaussian variables). Qualitative variables will be
compared using the chi 2 test or the Fisher test as appropriate.
A logistic regression will be used to identify risk factors of airway failure. A
multivariate model will be established.
A p-value of < and = 0.05 will be considered statistically significant. The statistical
analysis will be performed by the medical statistical department of the Montpellier
University Hospital with the help of statistical software (SAS, version 9.3; SAS Institute;
Cary, NC and R, version 2.14.1).
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