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

NCT03919331 | Unknown

• 1 other identifier: APHP180138
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

High flow nasal canula / P-SILI/ AHRF / EIT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Tidal volume under high flow nasal canula (HFNC)

  Day 0, Day 1 and Day 2

• Phase angle computed by respiratory inductance plethysmography (RIP)

  Day 0, Day 1 and Day 2

• Respiratory rate

  Day 0, Day 1 and Day 2

• pH under high flow nasal canula (HFNC)

  Day 0, Day 1 and Day 2

• PaO2 under high flow nasal canula (HFNC)

  Day 0, Day 1 and Day 2

Study Arms (1)

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.

Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil

Créteil, 94010, France

Location

Related Publications (11)

• 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.

  PMID: 9700176 BACKGROUND

• 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. doi: 10.1007/s00134-001-1114-4. Epub 2001 Oct 16.

  PMID: 11810114 BACKGROUND

• 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. doi: 10.1164/ajrccm.160.5.9903015.

  PMID: 10556125 BACKGROUND

• 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, 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.

  PMID: 25981908 BACKGROUND

• Carteaux 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.

  PMID: 26584191 BACKGROUND

• 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.

  PMID: 29099420 BACKGROUND

• 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.

  PMID: 27626833 BACKGROUND

• 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.

  PMID: 23857440 BACKGROUND

• 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.

  PMID: 27518321 BACKGROUND

• 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.

  PMID: 19410206 BACKGROUND

• Tuffet 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.

  PMID: 39578265 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Guillaume CARTEAUX, Doctor

  Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume CARTEAUX, Doctor

CONTACT

+331 49 81 43 85; Guillaume.carteaux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 18, 2019
• Study Start: June 1, 2019
• Primary Completion: June 3, 2021
• Study Completion: September 1, 2021
• Last Updated: May 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)