Acute Hypoxemic Respiratory FailureIVOXYNCT03919331
Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
A study testing Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC) in people with Acute Hypoxemic Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Créteil, 94010
Guillaume CARTEAUX, Doctor, +331 49 81 43 85, Guillaume.carteaux@aphp.fr
About this study
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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
- Keywords
- High flow nasal canula / P-SILI/ AHRF / EIT
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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. Receives: Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of high flow nasal canula (HFNC) at day 28
Failure of HFNC is defined as death or need for invasive mechanical ventilation
Measured: Day 28
Secondary outcomes (9)
Tidal volume under high flow nasal canula (HFNC)
Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)
Measured: Day 0, Day 1 and Day 2
Phase angle computed by respiratory inductance plethysmography (RIP)
Phase angle will be measured by respiratory inductance plethysmography
Measured: Day 0, Day 1 and Day 2
Respiratory rate
respiratory rate will be measured at each evaluation
Measured: Day 0, Day 1 and Day 2
pH under high flow nasal canula (HFNC)
pH will be measured via Blood gases
Measured: Day 0, Day 1 and Day 2
PaO2 under high flow nasal canula (HFNC)
PaO2 will be measured via Blood gases
Measured: Day 0, Day 1 and Day 2
PaCO2 under high flow nasal canula (HFNC)
PaCO2 will be measured via Blood gases
Measured: Day 0, Day 1 and Day 2
SaO2 under high flow nasal canula (HFNC)
SaO2 will be measured via Blood gases
Measured: Day 0, Day 1 and Day 2
Regional tidal volume.
computed by Electrical Impedance Tomography
Measured: Day 0, Day 1 and Day 2
Mortality
Mortality at Day 28, Day 90
Measured: Day 28, Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Jun 2019 (estimated)
- Primary completion3 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume CARTEAUX, Doctor, Principal investigator, Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919331
- Sponsor's protocol ID
- APHP180138
- Acronym
- IVOXY
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35. doi: 10.1056/NEJM199808133390703.
PubMed 9700176Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. doi: 10.1007/s00134-001-1114-4. Epub 2001 Oct 16.
PubMed 11810114Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91. doi: 10.1164/ajrccm.160.5.9903015.
PubMed 10556125Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Carteaux G, Millan-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.
PubMed 26584191Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.
PubMed 29099420Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
PubMed 27626833Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.
PubMed 23857440Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.
PubMed 27518321Hammer J, Newth CJ. Assessment of thoraco-abdominal asynchrony. Paediatr Respir Rev. 2009 Jun;10(2):75-80. doi: 10.1016/j.prrv.2009.02.004. Epub 2009 Apr 9.
PubMed 19410206Tuffet S, Boujelben MA, Haudebourg AF, Maraffi T, Perier F, Labedade P, Moncomble E, Gendreau S, Lacheny M, Vivier E, Mekontso-Dessap A, Carteaux G. High flow nasal cannula and low level continuous positive airway pressure have different physiological effects during de novo acute hypoxemic respiratory failure. Ann Intensive Care. 2024 Nov 23;14(1):171. doi: 10.1186/s13613-024-01408-w.
PubMed 39578265
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
- ClinicalTrials.gov ID
- NCT03919331
- Acronym / sponsor ID
- IVOXY / APHP180138
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- High flow nasal canula / P-SILI/ AHRF / EIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 3 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)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 | Diagnostic test | Experimental |
Primary outcome
Failure of high flow nasal canula (HFNC) at day 28
Time frame: Day 28
Failure of HFNC is defined as death or need for invasive mechanical ventilation
9 secondary outcomes
Tidal volume under high flow nasal canula (HFNC)
Time frame: Day 0, Day 1 and Day 2
Phase angle computed by respiratory inductance plethysmography (RIP)
Time frame: Day 0, Day 1 and Day 2
Respiratory rate
Time frame: Day 0, Day 1 and Day 2
pH under high flow nasal canula (HFNC)
Time frame: Day 0, Day 1 and Day 2
PaO2 under high flow nasal canula (HFNC)
Time frame: Day 0, Day 1 and Day 2
PaCO2 under high flow nasal canula (HFNC)
Time frame: Day 0, Day 1 and Day 2
SaO2 under high flow nasal canula (HFNC)
Time frame: Day 0, Day 1 and Day 2
Regional tidal volume.
Time frame: Day 0, Day 1 and Day 2
Mortality
Time frame: Day 28, Day90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 9700176Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35. doi: 10.1056/NEJM199808133390703.
- Background: PubMed 11810114Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. doi: 10.1007/s00134-001-1114-4. Epub 2001 Oct 16.
- Background: PubMed 10556125Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91. doi: 10.1164/ajrccm.160.5.9903015.
- Background: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- Background: PubMed 26584191Carteaux G, Millan-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.
- Background: PubMed 29099420Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.
- Background: PubMed 27626833Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
- Background: PubMed 23857440Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.
- Background: PubMed 27518321Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.
- Background: PubMed 19410206Hammer J, Newth CJ. Assessment of thoraco-abdominal asynchrony. Paediatr Respir Rev. 2009 Jun;10(2):75-80. doi: 10.1016/j.prrv.2009.02.004. Epub 2009 Apr 9.
- Derived from this study: PubMed 39578265Tuffet S, Boujelben MA, Haudebourg AF, Maraffi T, Perier F, Labedade P, Moncomble E, Gendreau S, Lacheny M, Vivier E, Mekontso-Dessap A, Carteaux G. High flow nasal cannula and low level continuous positive airway pressure have different physiological effects during de novo acute hypoxemic respiratory failure. Ann Intensive Care. 2024 Nov 23;14(1):171. doi: 10.1186/s13613-024-01408-w.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume CARTEAUX, Doctor principal investigator
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC) in people with Acute Hypoxemic Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume CARTEAUX, Doctor (+331 49 81 43 85, Guillaume.carteaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of high flow nasal canula (HFNC) at day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919331, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.