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Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo (IVOXY)

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Hypoxemic Respiratory Failure focused on measuring High flow nasal canula / P-SILI/ AHRF / EIT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old
  • HFNC initiated as part of the care
  • Respiratory rate > 25 / minute
  • PaO2/FiO2 ratio < 300 mm Hg
  • PaCO2 < 45 mm Hg
  • Affiliated with a social security system
  • Informed consent signed by the patient, trusted person or family member if the patient is unable to consent

Exclusion Criteria:

  • Acute cardiogenic pulmonary edema
  • Underlying chronic respiratory disease
  • Asthma exacerbation
  • Chronic obstructive pulmonary disease Exacerbation
  • Hemodynamic instability, defined as systolic arterial blood pressure < 90 mm Hg or mean arterial blood pressure < 65 mm Hg or the use of vasopressors
  • Glasgow Coma Score <= 12
  • Contraindication to CPAP (maxillofacial surgery, facial trauma)
  • Refusal of the patient to perform the CPAP test
  • Need for emergency intubation according to the clinician in charge of the patient
  • Patient protected by law
  • Pregnancy or breastfeeding woman

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Every adult patient admitted to the medical intensive care unit for de novo acute hypoxemic respiratory failure, and placed under hign flow nasal canula (HFNC). Inclusion and exclusion criterion are listed elsewhere.

Outcomes

Primary Outcome Measures

Failure of high flow nasal canula (HFNC) at day 28
Failure of HFNC is defined as death or need for invasive mechanical ventilation

Secondary Outcome Measures

Tidal volume under high flow nasal canula (HFNC)
Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)
Phase angle computed by respiratory inductance plethysmography (RIP)
Phase angle will be measured by respiratory inductance plethysmography
Respiratory rate
respiratory rate will be measured at each evaluation
pH under high flow nasal canula (HFNC)
pH will be measured via Blood gases
PaO2 under high flow nasal canula (HFNC)
PaO2 will be measured via Blood gases
PaCO2 under high flow nasal canula (HFNC)
PaCO2 will be measured via Blood gases
SaO2 under high flow nasal canula (HFNC)
SaO2 will be measured via Blood gases
Regional tidal volume.
computed by Electrical Impedance Tomography
Mortality
Mortality at Day 28, Day 90

Full Information

First Posted
March 26, 2019
Last Updated
May 14, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03919331
Brief Title
Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
Acronym
IVOXY
Official Title
Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
June 3, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
De novo acute hypoxemic respiratory failure (AHRF) is associated with high overall mortality, which increases significantly with the use of orotracheal intubation. High flow nasal canula (HFNC) has turned to be the first line non-invasive oxygenation strategy aiming to avoid intubation. One of the main factors worsening lung injury and increasing mortality in invasively ventilated patients is a too high tidal volume (TV) delivered by the ventilator. Consistent data suggest that such an aggravation of respiratory lesions may occur during spontaneous ventilation if TV is too large. This phenomenon is called Patient self-inflicted lung injury (P-SILI). The effect of TV on the outcome of patients with de novo AHRF under HFNC has never been evaluated since TV is not easily accessible in patients under HFNC. Investigators hypothesized that a large TV during HFNC has an impact on the outcome. TV will be measured using chest Electrical Impedance Tomography (EIT). To calibrate the EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. Thus, EIT signal can be used to calculate TV during HFNC since it remains reliable even when the positive expiratory pressure changes. A secondary objective is to quantify a respiratory distress index. This quantification will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle Investigators want to be able to evaluate up to 6 predictors of HFNC failure in this research with an effect size of 0.15, α risk of 0.05, and a power of 0.8. A number of 55 participants is required. Investigators plan to include 60 patients due to potential withdrawal of consent and/or unusable data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
High flow nasal canula / P-SILI/ AHRF / EIT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Tidal volume (TV) during high flow nasal canula (HFNC) will be measured using chest Electrical Impedance Tomography (EIT). To calibrate EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. The quantification of respiratory distress index will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Every adult patient admitted to the medical intensive care unit for de novo acute hypoxemic respiratory failure, and placed under hign flow nasal canula (HFNC). Inclusion and exclusion criterion are listed elsewhere.
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
Intervention Description
After information and consent, patients under HFNC for de novo acute hypoxemic respiratory failure will undergo a ten minutes 4cmH2O continuous positive airway pressure(CPAP) test while monitored with 1)chest Electrical Impedance Tomography (EIT) 2) a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece and connected to a differential pressure sensor, and 3) respiratory inductance plethysmography (RIP). Airway flow signal will be acquired using an analog/digital converter and stored for further analysis with acknowledge software. This will allow converting EIT data into tidal volume (TV), and estimating TV under HFNC. RIP signals will allow evaluating asynchronism between chest and abdomen by calculating the phase angle, thus quantifying respiratory distress. Patients monitored with an arterial catheter, arterial blood gas measurements will be done during CPAP and HFNC. These measures will be collected the first day of HFNC, and everyday up to three days
Primary Outcome Measure Information:
Title
Failure of high flow nasal canula (HFNC) at day 28
Description
Failure of HFNC is defined as death or need for invasive mechanical ventilation
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Tidal volume under high flow nasal canula (HFNC)
Description
Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)
Time Frame
Day 0, Day 1 and Day 2
Title
Phase angle computed by respiratory inductance plethysmography (RIP)
Description
Phase angle will be measured by respiratory inductance plethysmography
Time Frame
Day 0, Day 1 and Day 2
Title
Respiratory rate
Description
respiratory rate will be measured at each evaluation
Time Frame
Day 0, Day 1 and Day 2
Title
pH under high flow nasal canula (HFNC)
Description
pH will be measured via Blood gases
Time Frame
Day 0, Day 1 and Day 2
Title
PaO2 under high flow nasal canula (HFNC)
Description
PaO2 will be measured via Blood gases
Time Frame
Day 0, Day 1 and Day 2
Title
PaCO2 under high flow nasal canula (HFNC)
Description
PaCO2 will be measured via Blood gases
Time Frame
Day 0, Day 1 and Day 2
Title
SaO2 under high flow nasal canula (HFNC)
Description
SaO2 will be measured via Blood gases
Time Frame
Day 0, Day 1 and Day 2
Title
Regional tidal volume.
Description
computed by Electrical Impedance Tomography
Time Frame
Day 0, Day 1 and Day 2
Title
Mortality
Description
Mortality at Day 28, Day 90
Time Frame
Day 28, Day90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old HFNC initiated as part of the care Respiratory rate > 25 / minute PaO2/FiO2 ratio < 300 mm Hg PaCO2 < 45 mm Hg Affiliated with a social security system Informed consent signed by the patient, trusted person or family member if the patient is unable to consent Exclusion Criteria: Acute cardiogenic pulmonary edema Underlying chronic respiratory disease Asthma exacerbation Chronic obstructive pulmonary disease Exacerbation Hemodynamic instability, defined as systolic arterial blood pressure < 90 mm Hg or mean arterial blood pressure < 65 mm Hg or the use of vasopressors Glasgow Coma Score <= 12 Contraindication to CPAP (maxillofacial surgery, facial trauma) Refusal of the patient to perform the CPAP test Need for emergency intubation according to the clinician in charge of the patient Patient protected by law Pregnancy or breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume CARTEAUX, Doctor
Phone
+331 49 81 43 85
Email
Guillaume.carteaux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CARTEAUX, Doctor
Organizational Affiliation
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume CARTEAUX, Doctor
Phone
+331 49 81 43 85
Email
Guillaume.carteaux@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo

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