Respiratory Failure With Hypoxia Clinical Trial
Official title:
Assessment of Tidal Volume by Electrical Impendance Tomography During Non Invasive Oxygenation Techniques in de Novo Hypoxemic Acute Respiratory Failure
High Tidal volume is one of the main mechanisms that lead to lung injuries under mechanical ventilation (ventilator induced lung injury: VILI). It could also induce lung damage during spontaneous or assisted ventilation (patient-self inflicted lung injury: P-SILI). Different non invasive oxygenation devices are available to deliver oxygen during acute hypoxemic respiratory failure: high concentration mask, high flow nasal canula and non-invasive ventilation (with bucco-nasal mask or helmet). The investigators hypothesized that the device may influence the tidal volume. Therefore, the objective of this study is to measure and compare the tidal volume during the use of each device. Tidal volume will be measured using Electrical impedence tomography.
Background : De novo acute respiratory failure with moderate to severe hypoxemia is
associated with high intubation and mortality rates. Under non-invasive ventilation (NIV)
with a bucco-nasal mask, a high Tidal volume is associated with NIV failure and poor outcome.
It is suspected that non-control of the Tidal volume may worsen the prognosis of the patient.
Indeed, it is logical to consider that the physiopathological mechanisms that lead to
ventilator induced lung injury (VILI) under mechanical ventilation, especially
over-distension, can in the same way aggravate pulmonary lesions under NIV and even during
spontaneous breathing. The value of the Tidal volume is available in non-invasive ventilation
with the bucco-nasal mask, but it is unknown with the use of other non-invasive oxygenation
techniques : oxygen therapy with the high concentration mask, non-invasive ventilation with
the helmet, and high flow nasal canula.
Objectives : The main objective is to compare the Tidal volume received under different
oxygenation techniques (oxygen therapy with high concentration mask, NIV with bucco-nasal
mask and with helmet, high flow nasal canula), in patients with de novo acute hypoxemic
respiratory failure and moderate to severe hypoxemia.
Methods : All patients admitted in intensive care for de novo acute hypoxemic respiratory
failure, non hypercapnic, with moderate to severe hypoxemia (PiO2/FiO2 < 200 mmHg) will be
included. Patients with one of the following items will be excluded : chronic respiratory
disease, cardiogenic pulmonary edema, hemodynamic instability, coma, contraindication to NIV,
indication for immediate intubation.
After inclusion, the Tidal volume will be measured for each technique with the use of
electrical impedance tomography, in a random order. Randomisation will be carried out by
using sealed envelopes containing a predetermined order. Each technique will be used for 15
minutes. For NIV with the bucco-nasal mask, the inspiratory pressure will be progressively
adjusted to maintain the Tidal volume between 6 and 8 ml/kg of ideal body weight without
dropping below 7 cm H2O and the positive expiratory pressure will be gradually increased to 5
cm H2O. For NIV with the helmet, the inspiratory pressure will be progressively increase to
12 cm H2O and the positive expiratory pressure will be gradually increased to 5 cm H2O. For
high flow nasal canula,the gas flow will be set at 50 L/minute. FiO2 will be adjusted to keep
SpO2 above 92%. To convert the thoracic impedance variations into absolute values of Tidal
volumes, the airway flow signal will be collected with a pneumotacograph during the NIV with
bucco-nasal mask session. The following data will also be collected : respiratory rate,
comfort, regional Tidal volume in dependent and non-dependent areas and global inhomogeneity
index, Pa02, PaCO2 and pH (If an arterial catheter is present). Signed consent will be
required prior to any inclusion.
Expected benefits : This study will provide a better understanding of P-Sili and help define
the place each non-invasive oxygenation techniques in the management of de novo acute
respiratory failure.
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