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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02253667
• Other study ID #: PalliativeHFONC
• Status: Withdrawn
• Phase: N/A
• First received: September 28, 2014
• Last updated: January 24, 2017
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Disease
• Lung Diseases
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• HFONC

• Conventional oxygen therapy

Locations

Country	Name	City	State
Portugal	University Hospital of São João	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnoea	We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.	2 days
Primary	Opioids	By randomizing the two groups we will be able to compare the total use of opioids.	2 days
Secondary	Physiologic variables	The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.	2 days
Secondary	Patient comfort	Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.	2 days
Secondary	Mortality	Overall mortality in hospital and at 3 months and 6 months after discharge.	6 months