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

NCT02253667 | Withdrawn

• 1 other identifier: PalliativeHFONC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease; Acute Respiratory Distress Syndrome

Keywords

Palliative care; Lung disease; Acute Respiratory Distress Syndrome; High-flow oxygen nasal cannula; Dyspnoea; Opioids

Outcome Measures

Primary Outcomes (2)

• Dyspnoea

  We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.

  2 days

• Opioids

  By randomizing the two groups we will be able to compare the total use of opioids.

  2 days

Secondary Outcomes (3)

• Physiologic variables

  2 days

• Patient comfort

  2 days

• Mortality

  6 months

Study Arms (2)

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%.

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%.

Device: Conventional oxygen therapy

Interventions

HFONC DEVICE

Also known as: Optiflow (Fisher&Paykel ™)

HFONC

Conventional oxygen therapy DEVICE

Also known as: Venturi mask, Reservoir mask

Conventional oxygen

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

University Hospital of São João

Porto, Porto District, 4200-319, Portugal

Location

MeSH Terms

Conditions

Lung Diseases; Respiratory Distress Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel R Gonçalves, PhD

  Pulmonology Department, University Hospital São João

  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: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, PH.D

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

PT (1)