- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562000
PReventing EXtubation FAILure Related to Cough (PREXFAIL)
PReventing EXtubation FAILure by Cough Assistance and NIV in a Population Selected on Cough Peak Flow
After the admission in ICU, most patients have to be intubated in order to control haematosis in case of acute respiratory failure, to reduce the metabolic crisis during severe haemodynamic shock, or to protect upper airways in case of impairment of consciousness. After the initial phase of etiological treatment, as soon as the patients no more required the intubation, weanibility has to be checked (thanks to a weaning trial with or without pressure support) before the separation attempt is decided on an evaluation of the overall extubability, based in particular on a subjective assessment of cough strength. The cases of re-intubation can be related to several factors such as: i) a ventilatory insufficiency indicating an imbalance between the muscular pomp function and the mechanical constraint of the chest; ii) an acute cardiogenic oedema; iii) an obstruction of the superior airways, possibly due to an imbalance between the bronchial overload and the cough efficacy.
Preventing extubation failure should avoid exposing such patients to an over-risk of morbidity and mortality due to the consequences of a prolonged invasive ventilation. This prevention can be implemented thanks to an early detection of the patients the most at risk and then a coherent intervention to manage of each risk factor involved. For example, the inspiratory insufficiency can be fixed by the use of Non-Invasive Ventilation (NIV), as proposed for patients developing a final hypercapnia at the end of the weanibility test.
Several studies have been conducted to improve the prediction of extubation failure. As this is notably influenced by the cough efficacy before extubation, it has been proposed to assess the peak flow expiratory during voluntary cough. The Cough Peak Flow could for example replaced some semi-quantitative measures of cough strength associated to a low reproducibility. The most validated threshold for a weak cough is < 60 L/min and it has recently been demonstrated that it remained valuable when directly assessed using the built-in ventilator flow-meter.
In the meantime, new devices of mechanical cough assistance have been developed and are frequently used for patients presenting a chronic neuro-muscular disease affecting their ability to spontaneously clear their airways from an inappropriate bronchial overload. However, the interest of such devices for a systematic use after extubation has not been validated with a sufficient level of evidence to be recommended, in particular because of the bias of the single randomised monocentric study.
The main objective of the study consists in demonstrating in an open multicentre randomised study (focused on the patients with an objective low cough strength) the superiority of a systematic strategy combining mechanical cough assistance and non-invasive ventilation on standard care (manual post-extubation physiotherapy and NIV for restrictive indications) to reduce the re-intubation rate at 48h.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bron, France, 69500
- Hospices Civils de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients older than 18 years
- Patients intubated for more than 24h before the extubation attempt
- Patients able to follow simple commands (M6 response at the GCS) and to provide a signed agreement (or, in case of neurological impairment, to confirm to a third person their will to be included in the study by their appropriate code).
- Successful weaning trial with a low pressure support (7 cmH2O) during 30-60 min or longer in case of neuromuscular disorders and with PEEP=0 cmH2O
- Patients included for their first extubation attempt after a successful weaning trial based on classic weaning criteria (with the exception of: self-extubation, accidental extubation, extubation after less than 24 hours of ventilation).
- No decision of care limitation on respiratory failure (reintubation considered).
- Informed consent form signed by the patient (if cognitive capacities are preserved despite intubation) or by relatives (if cognitive and judgment capacities are impaired but with a capacity to respond to instructions sufficient to carry out spirometric measurements).
- Randomisation if the cough is objectively assessed as weak (CPF < 60 L/min et VT < 0.55 L). In other case, the patient with a strong cough are only included in an observational study with an outcome assessment.
Exclusion Criteria:
- Patient with tracheostomy
- Weaning trial conducted without a pressure support technique during the last test
- Failure of a weaning trial using a pressure support technique
- Decision not to extubate after a successful weaning trial
- Extubation of a patient already included after a previous extubation
- Final extubation
- Patients not affiliated to French health care system
- Patients in poor medical condition (hemodynamic, respiratory instability)
- Patients moribund or with previous decision of care limitation
- Absence of informed consent document or patient under legal protection
- Any clinical argument for a laryngeal oedema
- No possibility of CPF assessment: ventilator non-adapted for assessment, no comprehension of the cough order despite a M6 response at the GCS (no coughing effort initiated).
- Patient previously using a mechanical cough assistance
- Deglutition disorders objectified or supposed (severe lesion of the brainstem), with a theoretical risk of tracheostomy
- Contra-indication to mechanical cough assistance: pneumothorax or any lesion at risk of pneumothorax (such as costal fracture, emphysema, previous pneumothorax or other barotraumatism)
- Contra-indication to Non-Invasive Ventilation: agitation, non-treated pneumothorax, thoracic wound, severe vomiting, active digestive haemorrhage with hematemesis, severe cranio-facial traumatism with pneumo-encephaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention group on cough and ventilation assistance
Mechanical cough assistance during physiotherapy post-extubation in ICU and systematic indication of NIV.
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A standardised bundle of intervention will be tested using the combination of two medical devices previously used in daily clinical practice but without guideline and objective selection criteria, namely:
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Other: Control group on cough and ventilation assistance
Control group of extubated patients receiving the current gold standard strategy during physiotherapy after extubation in ICU and with selected indications of NIV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-intubation rate, including every cause
Time Frame: 48 hours
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Re-intubation rate, including every causes evaluated at 48h (expressed as a percentage). The causes could including include cardiac arrest, acute haemodynamic failure, acute neurological failure (agitation or increased loss of wakefulness compared to the initial state), acute respiratory failure (clinical signs of ARF, namely increased breathing rate > 40/min, pH < 7.35, SpO2 < 92% during > 5 min using a Fi = 1, repeated desaturations, intolerance to Non Invasive Ventilation). Any death before 48h is considered as an extubation failure, whatever its cause. |
48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the efficacy on mortality.
Time Frame: 90 days or the duration of the hospitalisation.
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Assessing the mortality rate at 90 days post-randomisation/extubation and assessing complementarily the mortality rate at the ICU discharge and at the hospital discharge.
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90 days or the duration of the hospitalisation.
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Evaluation of the efficiency on ICU care management
Time Frame: 90 days or the duration of the hospitalisation.
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Assessing the re-intubation rate at 7 days post-randomisation/extubation and assessing the overall extubation failure during the ICU hospitalisation (as a composite of the re-intubation rate and the tracheostomy rate).
Describing the causes of re-intubation (related to bronchial overload, opposed to other causes such as acute pulmonary oedema, which will be analysed separately) and the post-extubation nosocomial pneumonia leading to a curative antibiotherapy in ICU.
Assessing at 90 days post-randomisation/extubation the number of days without invasive respiratory support and without any respiratory support.
Defining qualitatively the respiratory function at 90 days post-randomisation/extubation (dyspnoea, persistent bronchial overload, continuing physiotherapy).
Describing the duration of: standard oxygenation, NIV after the first extubation, invasive ventilation after the first extubation, ICU stay and in-hospital stay.
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90 days or the duration of the hospitalisation.
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Assessment of the clinical and biological efficacy of the cough assistance
Time Frame: 24 hours
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Comparing between the two groups: i) a semi-quantitatively evaluation of the bronchial overload before extubation and after the first physiotherapy treatment post extubation (with and without intervention, respectively) using a convenient "Bronchial Overload scale" build on a Likert basis defined between 1 (low bronchial overload with a better excepted extubation outcome) to 5 (high bronchial overload with a worse excepted extubation outcome) and assessed by an third party; ii) the difference of arterial blood gas (with and without mechanical intervention on cough, respectively).
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24 hours
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Assessment of the clinical tolerance of the intervention
Time Frame: 7 days
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Assessing the number of treatment cessation due to tolerance issue and defined as Adverse Effects and Serious Adverse Effects.
Describing the haemodynamic profiles of patient in both groups during the physiotherapy (with and without mechanical intervention on cough, respectively).
Assessing the number of mechanical treatment failure requiring a change of the physiotherapy technique.
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7 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: GOBERT Florent, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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