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

NCT03406572 | Completed

• 1 other identifier: K160911J
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercapnic Respiratory Failure

Keywords

Acute on chronic respiratory failure; High-Flow heated and humidified nasal oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Number of ventilator-free days (VFDs) alive

  At day 28 after study enrollment

Secondary Outcomes (35)

• Delay of completion of stopping rules for NIV

  28 days post-randomisation

• Patient self-assessement of comfort during each SB period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome)

  After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days

• Nurse assessement of comfort during each SB period measured by Likert scale (score range1-5; higher values represent a better outcome)

  After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days

• Hospital length of stay

  28 days post-randomisation

• All cause mortality

  28 days post-randomisation

Study Arms (2)

HFHO Group

EXPERIMENTAL

Patients will receive a first NIV session (for 2 hours) with predefined parameters, and ABG will be performed between one and two hours of starting NIV. NIV will be extended according to ABG result (i.e. extended if pH \< 7.30). Switch from NIV to oxygen will require predefined criteria. In-between each NIV session, oxygen will be delivered using a high flow nasal cannula, with a flow of 50-60L/min and a FiO2 set to reach a targeted SpO2: 88%≤SpO2 ≤ 92%. Predefined criteria will be used to resume NIV.

Device: HFHO Group

Standard O2 Group

ACTIVE COMPARATOR

NIV will be initiated based on the same criteria and with the same parameters as the HFHO group. ABG will also be performed between one and two hours and NIV extended according to ABG result (i.e. extended if pH \< 7.30). Switch from NIV to oxygen will require the same predefined criteria as the HFHO group. In-between each NIV session, oxygen will be delivered using standard low flow O2 to reach the same targeted SpO2: 88% ≤SpO2 ≤ 92%. Similar criteria will be used to resume NIV

Device: Standard O2

Interventions

HFHO Group DEVICE

* Common name: humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases * Brand name: Airvo 2

Also known as: High-flow heated and humidified nasal oxygen therapy (HFHO).

HFHO Group

Standard O2 DEVICE

Standard oxygen therapy

Standard O2 Group

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18 or above, admitted to an ICU, an intermediate care or a respiratory care unit;
• Chronic respiratory disease previously documented or strongly suspected on clinical, radiological and blood gazes data and pulmonary function tests, in connection with an obstructive respiratory disease (COPD, emphysema, overlap-syndrome (COPD + obstructive sleep apnoea) or mixed (bronchiectasis, obesity-hypoventilation syndrome))
• Patients requiring NIV for hypercapnic ARF (whatever the precipitating cause) i.e. with clinical signs of moderate to severe respiratory distress : dyspnea and /or respiratory rate \> 25/min and/or use of accessory respiratory muscles and/or paradoxical abdominal motion and/or signs of respiratory encephalopathy (sleepiness, asterixis, confusion); and respiratory acidosis on arterial blood gases, defined by pH\<7.35 and PaCO2 \> 45 mmHg despite the careful supply of oxygen and appropriate therapy that may include bronchodilators, corticosteroids and antibiotics

You may not qualify if:

• Contraindications to NIV;
• Purely restrictive lung disease (thoracic deformity, neuro-muscular pathology) and pure obstructive sleep apnoea (without spirometric disturbance or daytime gas anomaly)
• Immediate need for intubation (respiratory or cardiac arrest);
• Persistent hemodynamic instability (use of vasopressors for \> 1 hour);
• Multiple organ failure (score SOFA\>6);
• NIV treatement for \>3 consecutive hours (without any interruption) before admission to ICU, intermediate care, or respiratory care unit and before randomization;
• Anticipated difficulties to conduct NIV (facial trauma or deformation, edentulous patient);
• End stage chronic respiratory insufficiency (defined as use of NIV at home or CPAP treatment at home and life expectancy below 6 month);
• Non-treated pneumothorax;
• Impossibility to perform subjective assessment of dyspnea and comfort (cognitive impairment);
• Patient under guardianship or trusteeship;
• Pregnancy/breastfeeding;
• Decision to withhold or to withdraw life-sustaining treatments (including intubation)
• Moribund state
• Current participation in another clinical trial with an endpoint related to NIV.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier

Colombes, 92700, France

Location

Related Publications (1)

• Ricard JD, Dib F, Esposito-Farese M, Messika J, Girault C; REVA network. 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. BMJ Open. 2018 Sep 19;8(9):e022983. doi: 10.1136/bmjopen-2018-022983.

  PMID: 30232113 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jean-Damien Ricard

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: January 23, 2018
• Study Start: May 18, 2018
• Primary Completion: June 18, 2023
• Study Completion: August 18, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

FR (1)