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Assessment of Tidal Volume During Non Invasive Oxygenation Techniques (VOLHYPOX)

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ClinicalTrials.gov Identifier: NCT03445455
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Guillaume CARTEAUX, Henri Mondor University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Respiratory Failure With Hypoxia Device: Tidal volume measurement

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Tidal Volume by Electrical Impendance Tomography During Non Invasive Oxygenation Techniques in de Novo Hypoxemic Acute Respiratory Failure
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
De novo AHRF

Acute hypoxemic non hypercapnic respiratory failure with a PaO2/FiO2 ratio < 200.

The following oxygenation devices are used and assessed during routine care:

High concentration mask, High flow nasal canula, NIV using buco-nasal mask or Helmet.

Electro impedence tomography signal will be recorded throughout this assessement for tidal volume measurement

Device: Tidal volume measurement

Recording of thoracic impendance variations during different non-invasive oxygenation techniques.

Conversion to Tidal volume after calibration using the airway flow signal recorded during the NIV with bucco-nasal mask.





Primary Outcome Measures :
  1. Tidal volume [ Time Frame: Averaged value over the last 3 minutes of thoracic impedance recording ]
    in milliliter


Secondary Outcome Measures :
  1. pH [ Time Frame: After 15 minutes of using a non invasive oxygenation device ]
    Arterial blood gases will be collected only if an arterial catheter will be already inserted

  2. PaO2 [ Time Frame: After 15 minutes of using a non invasive oxygenation device ]
    in mm Hg; Arterial blood gases will be collected only if an arterial catheter will be already inserted

  3. PaCO2 [ Time Frame: After 15 minutes of using a non invasive oxygenation device ]
    in mm Hg; Arterial blood gases will be collected only if an arterial catheter will be already inserted

  4. Respiratory rate [ Time Frame: After 15 minutes of using a non invasive oxygenation device ]
    in cycle/min

  5. Comfort [ Time Frame: After 15 minutes of using a non invasive oxygenation device ]
    using a semiquantitative scale from 1 (the worst comfort) to 5 (the best comfort)

  6. Regional Tidal volume [ Time Frame: Averaged value over the last 3 minutes of thoracic impedance recording ]
    in milliliter

  7. Global inhomogeneity index [ Time Frame: Averaged value over the last 3 minutes of thoracic impedance recording ]
    in percentage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with de novo acute hypoxemic respiratory failure
Criteria

Inclusion Criteria:

  • Respiratory rate > 25 per minute
  • PaO2/FiO2 < 200 mmHg
  • PaCO2 < 45 mmHg
  • Signed consent by patient or relative

Exclusion Criteria:

  • Chronic respiratory disease
  • COPD exacerbation
  • Acute asthma
  • Cardiogenic pulmonary edema
  • Hemodynamic instability (systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg or use of catecholamines)
  • Coma (Glasgow coma scale < 12)
  • Contraindication to non-invasive ventilation
  • Indication to immediate intubation according to the physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445455


Contacts
Contact: Guillaume Carteaux, MD, PhD + 33 (0)1 49 8123 91 guilaume.carteaux@aphp.fr

Sponsors and Collaborators
Henri Mondor University Hospital
Investigators
Principal Investigator: Guillaume Carteaux, MD, PhD Henri Mondor Hospital

Responsible Party: Dr Guillaume CARTEAUX, Associate Professor, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT03445455     History of Changes
Other Study ID Numbers: 2017-A03560-53
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms