Hypercapnic Respiratory FailureHIGH FLOW ACRFNCT03406572
Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure
A study testing HFHO Group and Standard O2 in people with Hypercapnic Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- What is being tested?
- HFHO Group and Standard O2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2018to 18 Aug 2023
- 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
- 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
Who cannot join
- 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;
Show all 17Show fewer
- 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.
- No affiliation to social security (beneficial or assignee);
- Refusal to participate to the study (patient or legal representative or family member or close relative if present
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier
Colombes, 92700
About this study
Official title: Comparison of High Flow Nasal Cannula Oxygen and Conventional Oxygen Therapy on Ventilatory Support Duration During Acute-on-chronic Respiratory Failure: a Multicenter, Randomized, Controlled Trial
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.
Read more
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.
Read the detailed description
In both groups, treatment will start with a first NIV session of 2 hours, with arterial blood gas measurement between one hour and two hours after initiating the NIV session. The NIV will be extended for those patients with a pH < 7.30. In both groups, patients will be assessed for their tolerance of NIV and their ability to switch to spontaneous breathing every hour +/- 30 min, except during sleep (10 pm-8 am); they will be assessed for their tolerance of spontaneous breathing and for the need of resumption of NIV every 2 hours+/- 30 min and every 4 +/- 1 hours thereafter. To ensure the consistency of indications of NIV and invasive mechanical ventilation (IMV) across centers and reduce potential bias, NIV and IMV will be initiated and stopped in the same way in the two groups, using predefined criteria.
- Inclusion (day 0): informed consent, randomisation (HFHO group/standard O2 group), NIV initiation (for 2 hours), clinical and paraclinical exam including ABG, data collection
- Follow-up (day 1 to day 28) : NIV, clinical exam, ABG, data collection
- Conditions
- Hypercapnic Respiratory Failure
- Being tested
- HFHO Group, Standard O2
- Keywords
- Acute on chronic respiratory failure, High-Flow heated and humidified nasal oxygen therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFHO GroupDevice
Also called High-flow heated and humidified nasal oxygen therapy (HFHO).
- Common name: humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases
- Brand name: Airvo 2
Standard O2Device
Standard oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Standard O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days (VFDs) alive
Measured: At day 28 after study enrollment
Secondary outcomes (35)
Delay of completion of stopping rules for NIV
Measured: 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)
Measured: 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)
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Hospital length of stay
Measured: 28 days post-randomisation
All cause mortality
Measured: 28 days post-randomisation
Proportion of patients with facial skin erythema and/or ulceration
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Number of NIV sessions
Measured: 28 days post-randomisation
Duration of NIV sessions (hours)
Measured: 28 days post-randomisation
Number of days between the day the patient first meets criteria for NIV cessation and day 28 post-randomization
Measured: 28 days post-randomisation
Number of days between the day of initially achieving unassisted ventilation and day 28 post-randomization (i.e. after having successfully spent 48 consecutive hours of unassisted breathing)
Measured: 28 days post-randomisation
Proportion of patients achieving 48 consecutive hours of daytime unassisted breathing
Measured: 28 days post-randomisation
Proportion of patients requiring NIV resumption after 48 consecutive hours of daytime unassisted breathing
Measured: 28 days post-randomisation
Patient self-assessement of comfort during each NIV period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome)
Measured: after 1 hour of NIV, up to 28 days
Nurse assessement of comfort during each NIV period measured by Likert scale (score range1-5; higher values represent a better outcome)
Measured: after 1 hour of NIV, up to 28 days
Patient self-assessement of dyspnea during each SB period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Measured: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Nurse assessement of dyspnea during each SB period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Measured: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Patient self-assessement of dyspnea during each NIV period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Measured: after 1 hour of NIV, up to 28 days
Nurse assessement of dyspnea during each NIV period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Measured: after 1 hour of NIV, up to 28 days
Respiratory rate during SB periods
Measured: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Respiratory rate during NIV periods
Measured: after 1 hour of NIV, up to 28 days
Proportion of patients using accessory muscles during NIV periods
Measured: after 1 hour of NIV, up to 28 days
Daily arterial blood gases (ABG) (in terms of pH, PaCO2 and PaO2 measured between 8-10 am).
Measured: up to 28 days post-randomisation
Proportion of patients with premature NIV cessation (intolerance) (defined by agitation and/or mask removal, and/or patient's wish to interrupt session before)
Measured: 28 days post-randomisation
Proportion of patients refusing to resume NIV (despite meeting criteria)
Measured: 28 days post-randomisation
Proportion of patients who need secondary intubation and IMV
Measured: 28 days post-randomisation
Proportion of patients with nasal bridge ulceration
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with eye irritation
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal congestion
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal/oral dryness
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with gastric distension
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nosocomial pneumonia
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with pneumothorax
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with arterial hypotension
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nostril ulceration (including nasolabial angle, columella, nostril sill)
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nose bleeding
Measured: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start18 May 2018
- Primary completion18 Jun 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypercapnic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Jean-Damien Ricard, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406572
- Sponsor's protocol ID
- K160911J
- Acronym
- HIGH FLOW ACRF
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2017
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30232113
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Flow Nasal Cannula Oxygen and Conventional Oxygen Therapy on Ventilatory Support Duration During Acute-on-chronic Respiratory Failure: a Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03406572
- Acronym / sponsor ID
- HIGH FLOW ACRF / K160911J
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- Acute on chronic respiratory failure, High-Flow heated and humidified nasal oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 18 May 2018 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 23 Jan 2018 (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.
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.
Detailed description
In both groups, treatment will start with a first NIV session of 2 hours, with arterial blood gas measurement between one hour and two hours after initiating the NIV session. The NIV will be extended for those patients with a pH < 7.30. In both groups, patients will be assessed for their tolerance of NIV and their ability to switch to spontaneous breathing every hour +/- 30 min, except during sleep (10 pm-8 am); they will be assessed for their tolerance of spontaneous breathing and for the need of resumption of NIV every 2 hours+/- 30 min and every 4 +/- 1 hours thereafter. To ensure the consistency of indications of NIV and invasive mechanical ventilation (IMV) across centers and reduce potential bias, NIV and IMV will be initiated and stopped in the same way in the two groups, using predefined criteria.
- Inclusion (day 0): informed consent, randomisation (HFHO group/standard O2 group), NIV initiation (for 2 hours), clinical and paraclinical exam including ABG, data collection
- Follow-up (day 1 to day 28) : NIV, clinical exam, ABG, data collection
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFHO Group | Experimental | Device: HFHO GroupPatients 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. |
| Standard O2 Group | Active comparator | Device: Standard O2NIV 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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);
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 |
|---|---|---|
| HFHO GroupAlso: High-flow heated and humidified nasal oxygen therapy (HFHO).* Common name: humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases * Brand name: Airvo 2 | Device | HFHO Group |
| Standard O2Standard oxygen therapy | Device | Standard O2 Group |
Primary outcome
Number of ventilator-free days (VFDs) alive
Time frame: At day 28 after study enrollment
35 secondary outcomes
Delay of completion of stopping rules for NIV
Time frame: 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)
Time frame: 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)
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Hospital length of stay
Time frame: 28 days post-randomisation
All cause mortality
Time frame: 28 days post-randomisation
Proportion of patients with facial skin erythema and/or ulceration
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Number of NIV sessions
Time frame: 28 days post-randomisation
Duration of NIV sessions (hours)
Time frame: 28 days post-randomisation
Number of days between the day the patient first meets criteria for NIV cessation and day 28 post-randomization
Time frame: 28 days post-randomisation
Number of days between the day of initially achieving unassisted ventilation and day 28 post-randomization (i.e. after having successfully spent 48 consecutive hours of unassisted breathing)
Time frame: 28 days post-randomisation
Proportion of patients achieving 48 consecutive hours of daytime unassisted breathing
Time frame: 28 days post-randomisation
Proportion of patients requiring NIV resumption after 48 consecutive hours of daytime unassisted breathing
Time frame: 28 days post-randomisation
Patient self-assessement of comfort during each NIV period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome)
Time frame: after 1 hour of NIV, up to 28 days
Nurse assessement of comfort during each NIV period measured by Likert scale (score range1-5; higher values represent a better outcome)
Time frame: after 1 hour of NIV, up to 28 days
Patient self-assessement of dyspnea during each SB period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Nurse assessement of dyspnea during each SB period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Patient self-assessement of dyspnea during each NIV period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Time frame: after 1 hour of NIV, up to 28 days
Nurse assessement of dyspnea during each NIV period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Time frame: after 1 hour of NIV, up to 28 days
Respiratory rate during SB periods
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Respiratory rate during NIV periods
Time frame: after 1 hour of NIV, up to 28 days
Proportion of patients using accessory muscles during NIV periods
Time frame: after 1 hour of NIV, up to 28 days
Daily arterial blood gases (ABG) (in terms of pH, PaCO2 and PaO2 measured between 8-10 am).
Time frame: up to 28 days post-randomisation
Proportion of patients with premature NIV cessation (intolerance) (defined by agitation and/or mask removal, and/or patient's wish to interrupt session before)
Time frame: 28 days post-randomisation
Proportion of patients refusing to resume NIV (despite meeting criteria)
Time frame: 28 days post-randomisation
Proportion of patients who need secondary intubation and IMV
Time frame: 28 days post-randomisation
Proportion of patients with nasal bridge ulceration
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with eye irritation
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal congestion
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal/oral dryness
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with gastric distension
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nosocomial pneumonia
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with pneumothorax
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with arterial hypotension
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nostril ulceration (including nasolabial angle, columella, nostril sill)
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nose bleeding
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 30232113Ricard 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.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Damien Ricard principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFHO Group and Standard O2 in people with Hypercapnic 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 3 inclusion and 17 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: finished, as of the sponsor's last update on 6 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventilator-free days (VFDs) alive (time frame: At day 28 after study enrollment). 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 NCT03406572, which also lists 1 linked publication.
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 6 Sep 2023.