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Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients

Primary Purpose

Lung Disease, Acute Respiratory Distress Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
HFONC
Conventional oxygen therapy
Sponsored by
Hospital Sao Joao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Disease focused on measuring Palliative care, Lung disease, Acute Respiratory Distress Syndrome, High-flow oxygen nasal cannula, Dyspnoea, Opioids

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Sites / Locations

  • University Hospital of São João

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HFONC

Conventional oxygen

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

Dyspnoea
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
Opioids
By randomizing the two groups we will be able to compare the total use of opioids.

Secondary Outcome Measures

Physiologic variables
The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.
Patient comfort
Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.
Mortality
Overall mortality in hospital and at 3 months and 6 months after discharge.

Full Information

First Posted
September 28, 2014
Last Updated
January 24, 2017
Sponsor
Hospital Sao Joao
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1. Study Identification

Unique Protocol Identification Number
NCT02253667
Brief Title
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
Official Title
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
One of the investigators left the department, Master Degree in which this study was part of her thesis. No patients were enrolled.
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sao Joao

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Acute Respiratory Distress Syndrome
Keywords
Palliative care, Lung disease, Acute Respiratory Distress Syndrome, High-flow oxygen nasal cannula, Dyspnoea, Opioids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFONC
Arm Type
Experimental
Arm Description
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%.
Arm Title
Conventional oxygen
Arm Type
Other
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
HFONC
Other Intervention Name(s)
Optiflow (Fisher&Paykel ™)
Intervention Type
Device
Intervention Name(s)
Conventional oxygen therapy
Other Intervention Name(s)
Venturi mask, Reservoir mask
Primary Outcome Measure Information:
Title
Dyspnoea
Description
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
Time Frame
2 days
Title
Opioids
Description
By randomizing the two groups we will be able to compare the total use of opioids.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Physiologic variables
Description
The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.
Time Frame
2 days
Title
Patient comfort
Description
Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.
Time Frame
2 days
Title
Mortality
Description
Overall mortality in hospital and at 3 months and 6 months after discharge.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel R Gonçalves, PhD
Organizational Affiliation
Pulmonology Department, University Hospital São João
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal

12. IPD Sharing Statement

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Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients

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