NCT03406572: HIGH FLOW ACRF

Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure

Completed NA Last updated 6 September 2023

What this trial tests

NA trial testing HFHO Group in Hypercapnic Respiratory Failure in 161 participants. Completed in 18 August 2023.

Timeline

18 May 2018

Primary endpoint
18 June 2023

18 August 2023

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	161
Start date	18 May 2018
Primary completion	18 June 2023
Estimated completion	18 August 2023
Sites	1 location across France

Drugs / interventions tested

• HFHO Group
• Standard O2

Conditions studied

• Hypercapnic Respiratory Failure — all drugs for Hypercapnic Respiratory Failure →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Hypercapnic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic respiratory insufficiency and COPD are the third leading cause of death worldwide. Patients decompensate at various stages of their disease and exhibit acute-on-chronic respiratory failure (ACRF), a frequent cause of ICU hospitalization for hypercapnic acute respiratory failure (ARF). Non-invasive ventilation (NIV) is the first line ventilatory treatment for hypercapnic ARF. It is applied intermittently, separated by periods of spontaneous breathing (SB) with standard oxygen (O2).

Standard O2 has drawbacks that limit the benefit of intermittent NIV in hypercapnic ARF: limited gas flow which is well below the patient's inspiratory flow rate, limited capacity and efficiency of oxygenation with non-controlled FiO2 (risk of excessive oxygen and induced hypercapnia), and cold and dry gas leading to discomfort and under-humidification of the airways and tracheobronchial secretions. Benefits in terms of work of breathing and CO2 removal resulting from PEEP and pressure support applied during NIV periods could be rapidly lost during standard O2.

Recently, use of high-flow heated and humidified nasal oxygen therapy (HFHO) has gained enthusiasm among intensivists to manage ARF. HFHO delivers high flows (up to 60L/min, that generate moderate PEEP) of heated and humidified oxygen at a controlled and adjustable FiO2 (21 to 100%) that rapidly improve respiratory distress symptoms, oxygenation, respiratory comfort and outcome of patients with hypoxemic ARF.

These unique features of HFHO could overcome some of the drawbacks of standard O2 during SB periods in hypercapnic ARF. Indeed, PEEP effect, washout of nasopharyngeal dead-space limiting CO2 re-breathing and inspired gas conditioning preserving adequate mucosal function and secretion removal, could potentially contribute to decrease airways resistance, intrinsic PEEP and work of breathing, while improving patient comfort. Investigators aim to determine if the use of HFHO, as compared to standard O2, increases the number of ventilator-free days (VFDs) and alive at day 28 in patients with hypercapnic ARF admitted in an ICU, an intermediate care, or a respiratory care unit, and requiring NIV.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline.
   Rochwerg B, Einav S, Chaudhuri D, Mancebo J, et al · · 2020 · cited 238× · PMID 33201321 · DOI 10.1007/s00134-020-06312-y
2. Use of nasal high flow oxygen during acute respiratory failure.
   Ricard JD, Roca O, Lemiale V, Corley A, et al · · 2020 · cited 134× · PMID 32901374 · DOI 10.1007/s00134-020-06228-7
3. Prediction of outcome of nasal high flow use during COVID-19-related acute hypoxemic respiratory failure.
   Zucman N, Mullaert J, Roux D, Roca O, et al · · 2020 · cited 95× · PMID 32671470 · DOI 10.1007/s00134-020-06177-1
4. Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The 'HIGH-FLOW ACRF' study.
   Ricard JD, Dib F, Esposito-Farese M, Messika J, et al · · 2018 · cited 25× · PMID 30232113 · DOI 10.1136/bmjopen-2018-022983