Lung DiseaseNCT02253667
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
A study testing HFONC and Conventional oxygen therapy in people with Lung Disease and Acute Respiratory Distress Syndrome, run by Hospital Sao Joao at 1 site in Portugal.
Trial summary
The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively. Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Disease, Acute Respiratory Distress Syndrome
- What is being tested?
- HFONC and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2014to Sep 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis, COPD, …) - (McCabe score > 3 [<6 months life expectancy] and a Palliative Prognostic Index score ≥ 4) admitted to hospital because of acute respiratory failure and distress
- Had chosen to forego all life support and receiving only palliative care
- Severe hypoxemia (PaO2/FiO2< 250)
- At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory distress, and respiratory rate greater than 30 beats per min
Who cannot join
- Patients had to be competent (Kelly score <4)
- Refusal of treatment
- Weak cough reflex
- Agitation or non-cooperation
- Uncontrolled cardiac ischemia or arrhythmias
- Failure of more than two organs
Show all 10Show fewer
- Use of opioids within the past 2 weeks
- Adverse reactions to opioids
- History of substance misuse
- Known contraindication for morphine (acute renal failure and recent head injury)
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University Hospital of São João
Porto, Porto District, 4200-319
About this study
Official title: Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial
The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.
Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen.
Read more
Conventional oxygen supplementation is often used in these patients, but it may be inadequate, especially if they require high flows (from 30L/min to 120L/min in acute respiratory failure).
High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which generates the gas flow rate up to 55 L/min and a heated humidification system. This technology may have an important role in reducing respiratory distress in do-not-intubate patients.
Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration; a better matching between patient's inspiratory demand and oxygen flow; generation of a certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure and recruitment; improvement of lung and airway mucociliary clearance due to the heated and humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and speech.
The investigators hypothesize that patients supported with HFONC need less opioids to decrease dyspnoea.
- Conditions
- Lung Disease, Acute Respiratory Distress Syndrome
- Being tested
- HFONC, Conventional oxygen therapy
- Keywords
- Palliative care, Lung disease, Acute Respiratory Distress Syndrome, High-flow oxygen nasal cannula, Dyspnoea, Opioids
- Medical subject headings
- Lung Diseases, Respiratory Distress Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFONCDevice
Also called Optiflow (Fisher&Paykel ™)
Conventional oxygen therapyDevice
Also called Venturi mask, Reservoir mask
| Study group | Role | What they receive |
|---|---|---|
| HFONC | Experimental | Patient will use HFONC with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%. Receives: Device: HFONC |
| Conventional oxygen | Other | Patient will use venturi or reservoir mask with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%. Receives: Device: Conventional oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnoea
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
Measured: 2 days
Opioids
By randomizing the two groups we will be able to compare the total use of opioids.
Measured: 2 days
Secondary outcomes (3)
Physiologic variables
The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.
Measured: 2 days
Patient comfort
Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.
Measured: 2 days
Mortality
Overall mortality in hospital and at 3 months and 6 months after discharge.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: One of the investigators left the department, Master Degree in which this study was part of her thesis. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel R. Goncalves, Hospital Sao Joao
- Investigators
- Miguel R Gonçalves, PhD, Principal investigator, Pulmonology Department, University Hospital São João
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253667
- Sponsor's protocol ID
- PalliativeHFONC
- Status last verified
- Jan 2017
- First submitted
- 28 Sep 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02253667
- Acronym / sponsor ID
- PalliativeHFONC
- Conditions
- Lung Disease, Acute Respiratory Distress Syndrome
- Keywords
- Palliative care, Lung disease, Acute Respiratory Distress Syndrome, High-flow oxygen nasal cannula, Dyspnoea, Opioids
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the investigators left the department, Master Degree in which this study was part of her thesis. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- 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.
The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.
Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen.
Conventional oxygen supplementation is often used in these patients, but it may be inadequate, especially if they require high flows (from 30L/min to 120L/min in acute respiratory failure).
High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which generates the gas flow rate up to 55 L/min and a heated humidification system. This technology may have an important role in reducing respiratory distress in do-not-intubate patients.
Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration; a better matching between patient's inspiratory demand and oxygen flow; generation of a certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure and recruitment; improvement of lung and airway mucociliary clearance due to the heated and humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and speech.
The investigators hypothesize that patients supported with HFONC need less opioids to decrease dyspnoea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFONC | Experimental | Device: HFONCPatient will use HFONC with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%. |
| Conventional oxygen | Other | Device: Conventional oxygen therapyPatient will use venturi or reservoir mask with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis, COPD, …) - (McCabe score > 3 [<6 months life expectancy] and a Palliative Prognostic Index score ≥ 4) admitted to hospital because of acute respiratory failure and distress
- Had chosen to forego all life support and receiving only palliative care
- Severe hypoxemia (PaO2/FiO2< 250)
- At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory distress, and respiratory rate greater than 30 beats per min
Key exclusion criteria (10 listed)
- Patients had to be competent (Kelly score <4)
- Refusal of treatment
- Weak cough reflex
- Agitation or non-cooperation
- Uncontrolled cardiac ischemia or arrhythmias
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 |
|---|---|---|
| HFONCAlso: Optiflow (Fisher&Paykel ™) | Device | HFONC |
| Conventional oxygen therapyAlso: Venturi mask, Reservoir mask | Device | Conventional oxygen |
Primary outcome
Dyspnoea
Time frame: 2 days
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
Opioids
Time frame: 2 days
By randomizing the two groups we will be able to compare the total use of opioids.
3 secondary outcomes
Physiologic variables
Time frame: 2 days
Patient comfort
Time frame: 2 days
Mortality
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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.
Miguel R Gonçalves, PhD principal investigator
Pulmonology Department, University Hospital São João
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFONC and Conventional oxygen therapy in people with Lung Disease and Acute Respiratory Distress Syndrome, run by Hospital Sao Joao at 1 site in Portugal.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 25 Jan 2017. 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 Portugal. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dyspnoea (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2017.