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

Acute Hypoxemic Respiratory Failure Clinical Trial

— IVOXY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03919331
• Other study ID #: APHP180138
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Guillaume CARTEAUX, Doctor
• Phone: +331 49 81 43 85
• Email: Guillaume.carteaux[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (10)

Antonelli 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. Epub 2001 Oct 16. — View Citation

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. — View Citation

Brochard 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. — View Citation

Carteaux G, Millán-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. — View Citation

Chanques 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. — View Citation

Confalonieri 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. — View Citation

Frat 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. — View Citation

Frat 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, Béduneau G, Delétage-Métreau 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. — View Citation

Hammer 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. Review. — View Citation

Mauri 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of high flow nasal canula (HFNC) at day 28	Failure of HFNC is defined as death or need for invasive mechanical ventilation	Day 28
Secondary	Tidal volume under high flow nasal canula (HFNC)	Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)	Day 0, Day 1 and Day 2
Secondary	Phase angle computed by respiratory inductance plethysmography (RIP)	Phase angle will be measured by respiratory inductance plethysmography	Day 0, Day 1 and Day 2
Secondary	Respiratory rate	respiratory rate will be measured at each evaluation	Day 0, Day 1 and Day 2
Secondary	pH under high flow nasal canula (HFNC)	pH will be measured via Blood gases	Day 0, Day 1 and Day 2
Secondary	PaO2 under high flow nasal canula (HFNC)	PaO2 will be measured via Blood gases	Day 0, Day 1 and Day 2
Secondary	PaCO2 under high flow nasal canula (HFNC)	PaCO2 will be measured via Blood gases	Day 0, Day 1 and Day 2
Secondary	SaO2 under high flow nasal canula (HFNC)	SaO2 will be measured via Blood gases	Day 0, Day 1 and Day 2
Secondary	Regional tidal volume.	computed by Electrical Impedance Tomography	Day 0, Day 1 and Day 2
Secondary	Mortality	Mortality at Day 28, Day 90	Day 28, Day90